Trial Outcomes & Findings for Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis (NCT NCT03315130)
NCT ID: NCT03315130
Last Updated: 2022-07-27
Results Overview
The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for myasthenia gravis (MG). The scale consists of 13 individual assessments, each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the individual scores with a range of 0-39. Higher scores are representative of more severe impairment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
From Baseline to Week 12
Results posted on
2022-07-27
Participant Flow
The study started to enroll participants in October 2017 and concluded in November 2020.
The Participant flow refers to the Intent-to-treat Set for the main portion and Safety Set for the extension portion.
Participant milestones
| Measure |
RA101495 0.1 mg/kg
Participants received RA101495 0.1 milligram/kilogram (mg/kg) as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension portion, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion (EP).
|
RA101495 0.3 mg/kg
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for generalized myasthenia gravis (gMG). In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
Placebo
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants were randomized to receive either RA101495 0.1 mg/kg (up to 48 weeks) or RA101495 0.3 mg/kg (up to 122 weeks) in the extension portion, as a subcutaneous injection once daily.
|
RA101495 0.1 mg/kg (Before Switch) to 0.3 mg/kg (After Switch)
Following implementation of protocol amendment v3.0, and upon appropriate reconsent, all study participants ongoing in the extension portion who had previously received the RA101495 0.1mg/kg/day dose switched to receive the RA101495 0.3mg/kg/day until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
|---|---|---|---|---|
|
Main Portion (12 Weeks)
STARTED
|
15
|
15
|
15
|
0
|
|
Main Portion (12 Weeks)
COMPLETED
|
15
|
13
|
15
|
0
|
|
Main Portion (12 Weeks)
NOT COMPLETED
|
0
|
2
|
0
|
0
|
|
EP:Before Switch to 0.3 mg/kg(Week13-48)
STARTED
|
22
|
21
|
0
|
0
|
|
EP:Before Switch to 0.3 mg/kg(Week13-48)
COMPLETED
|
21
|
21
|
0
|
0
|
|
EP:Before Switch to 0.3 mg/kg(Week13-48)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
EP:After Switch to 0.3 mg/kg(Week48-122)
STARTED
|
0
|
21
|
0
|
21
|
|
EP:After Switch to 0.3 mg/kg(Week48-122)
COMPLETED
|
0
|
17
|
0
|
20
|
|
EP:After Switch to 0.3 mg/kg(Week48-122)
NOT COMPLETED
|
0
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
RA101495 0.1 mg/kg
Participants received RA101495 0.1 milligram/kilogram (mg/kg) as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension portion, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion (EP).
|
RA101495 0.3 mg/kg
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for generalized myasthenia gravis (gMG). In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
Placebo
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants were randomized to receive either RA101495 0.1 mg/kg (up to 48 weeks) or RA101495 0.3 mg/kg (up to 122 weeks) in the extension portion, as a subcutaneous injection once daily.
|
RA101495 0.1 mg/kg (Before Switch) to 0.3 mg/kg (After Switch)
Following implementation of protocol amendment v3.0, and upon appropriate reconsent, all study participants ongoing in the extension portion who had previously received the RA101495 0.1mg/kg/day dose switched to receive the RA101495 0.3mg/kg/day until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
|---|---|---|---|---|
|
Main Portion (12 Weeks)
Subject withdrew consent
|
0
|
1
|
0
|
0
|
|
Main Portion (12 Weeks)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
EP:Before Switch to 0.3 mg/kg(Week13-48)
Subject withdrew consent
|
1
|
0
|
0
|
0
|
|
EP:After Switch to 0.3 mg/kg(Week48-122)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
EP:After Switch to 0.3 mg/kg(Week48-122)
Subject withdrew consent
|
0
|
1
|
0
|
0
|
|
EP:After Switch to 0.3 mg/kg(Week48-122)
Death
|
0
|
2
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
RA101495 0.1 mg/kg
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion.
|
RA101495 0.3 mg/kg
n=15 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for generalized myasthenia gravis (gMG). In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
Placebo
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants were randomized to receive either RA101495 0.1 mg/kg (up to 48 weeks) or RA101495 0.3 mg/kg (up to 122 weeks) in the extension portion, as a subcutaneous injection once daily.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 15.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Population: The modified ITT (mITT) population included all participants in the ITT population who had received at least 1 dose of study drug.
The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for myasthenia gravis (MG). The scale consists of 13 individual assessments, each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the individual scores with a range of 0-39. Higher scores are representative of more severe impairment.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Change From Baseline to Week 12 in Quantitative Myasthenia Gravis (QMG) Score
|
-5.5 score on a scale
Standard Error 1.2
|
-6.0 score on a scale
Standard Error 1.2
|
-3.2 score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
The MG-ADL is a brief 8-item survey designed to evaluate MG symptom severity. The scale consists of 8 items each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the 8 individual scores with range of 0-24. Higher scores are associated with more severe symptoms of MG.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Change From Baseline to Week 12 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale
|
-3.3 score on a scale
Standard Error 0.9
|
-3.4 score on a scale
Standard Error 0.9
|
-1.1 score on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
The MG-QOL15r is a 15-item survey that was designed to assess quality of life in participants with MG. The survey consisted of 15 questions and the corresponding responses were each scored on a 0-2 point scale (0=Not much at all, 1=Somewhat, 2=Very Much). The total score is the sum of the 15 individual item scores with a range of 0-30. Higher scores indicate more severe impact of the disease on aspects of the participant's life.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Change From Baseline to Week 12 in the Myasthenia Gravis - Quality of Life 15r (MG-QOL15r) Survey
|
-7.4 score on a scale
Standard Error 1.7
|
-5.9 score on a scale
Standard Error 1.7
|
-2.1 score on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
The MG Composite is a 10-item scale that has been used to measure the clinical status of participants with MG, in order to evaluate treatment response. It consists of 10 items which included ptosis (score range=0 to 3), double vision on lateral gaze left/right/both (score range=0 to 4), eye closure (score range=0 to 2), talking (score range=0 to 6), chewing (score range=0 to 6), swallowing (score range=0 to 6), breathing (score range=0 to 9), neck flexion or extension (score range=0 to 4), shoulder abduction (score range=0 to 5) and hip flexion (score range= 0 to 5). The total score is the sum of the 10 individual scores with a range of 0-50. Higher scores in the MG Composite indicate more severe impairment due to the disease.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Change From Baseline to Week 12 in the MG Composite Scale Total Score
|
-5.3 score on a scale
Standard Error 1.5
|
-7.4 score on a scale
Standard Error 1.6
|
-3.3 score on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Week 12Population: The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for MG. The scale consists of 13 individual assessments, each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the individual scores with a range of 0-39. Higher scores are representative of more severe impairment.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Percentage of Participants With >= 3-point Reduction in QMG Total Score at Week 12
|
66.7 percentage of participants
|
71.4 percentage of participants
|
53.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
Percentage of participants who used at least 1 dose of rescue medication were reported.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Percentage of Participants Who Required Rescue Therapy Over the 12-week Treatment Period
|
6.7 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The safety population included all participants who had received at least 1 dose of study drug (i.e., mITT Population), with participants to be analyzed based on the actual treatment received.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulted in death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
15 Participants
|
12 Participants
|
14 Participants
|
|
Main Portion: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (Pre-dose)Population: The pharmacodynamic (PD) population included all participants in mITT Population who had at least 1 evaluable PD assessment.
A BioTek ELx800 automated microplate reader is used to measure the optical density at 415 nanometer (nm) of human plasma samples to calculate the percent lysis of sheep erythrocytes that has occurred as a result of total complement activity. The measure of complement activity is determined by the degree of hemolysis of the erythrocytes.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Change From Baseline in Sheep Red Blood Cell (sRBC) Lysis Assay at Week 12 (Pre-dose)
|
-81.822 percent lysis of sheep erythrocytes
Standard Error 2.469
|
-94.914 percent lysis of sheep erythrocytes
Standard Error 2.908
|
0.775 percent lysis of sheep erythrocytes
Standard Error 2.571
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (Pre-dose)Population: The PD population included all participants in mITT Population who had at least 1 evaluable PD assessment.
Blood samples were collected from participants to assess Complement Component 5C levels.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
n=15 Participants
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Change From Baseline in C5 Levels at Week 12 (Pre-dose)
|
57.349 micrograms/milliliter (ug/mL)
Standard Error 7.057
|
54.302 micrograms/milliliter (ug/mL)
Standard Error 6.804
|
-2.774 micrograms/milliliter (ug/mL)
Standard Error 6.237
|
SECONDARY outcome
Timeframe: 1, 3 and 6 hours postdose on Day 1; Pre-dose on Week 1, 2, 4, 8 and 12Population: The pharmacokinetic (PK) population included all participants in mITT population who had at least 1 evaluable PK assessment. Here "Number Analyzed" signifies number of participants who were evaluable at specified time points. 1 Participant (who was randomized to Placebo) mistakenly received Zilucoplan on Day 1 following a dispensing error (which was documented as a minor PD). Due to data confidentiality reasons, the results have not been reported for the placebo arm.
RA102758 and RA103488 are the metabolites of RA101495.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758- Day 1: 1 hour postdose
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above lower limit of quantification (LLOQ).
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758- Day 1: 3 hours postdose
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA101495- Week 2: Pre-dose
|
4914.200 nanograms/milliliter (ng/mL)
Standard Deviation 743.215
|
10222.846 nanograms/milliliter (ng/mL)
Standard Deviation 1662.869
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA101495- Week 4: Pre-dose
|
5100.286 nanograms/milliliter (ng/mL)
Standard Deviation 859.767
|
10265.917 nanograms/milliliter (ng/mL)
Standard Deviation 1604.004
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA101495- Week 8: Pre-dose
|
5222.067 nanograms/milliliter (ng/mL)
Standard Deviation 688.427
|
10075.000 nanograms/milliliter (ng/mL)
Standard Deviation 1872.400
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA101495- Week 12: Pre-dose
|
5281.333 nanograms/milliliter (ng/mL)
Standard Deviation 1122.372
|
10284.846 nanograms/milliliter (ng/mL)
Standard Deviation 1771.586
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758- Day 1: 6 hours postdose
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758- Week 1: Pre-dose
|
252.693 nanograms/milliliter (ng/mL)
Standard Deviation 78.909
|
849.743 nanograms/milliliter (ng/mL)
Standard Deviation 273.388
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758- Week 2: Pre-dose
|
408.847 nanograms/milliliter (ng/mL)
Standard Deviation 94.773
|
1473.431 nanograms/milliliter (ng/mL)
Standard Deviation 440.496
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758- Week 4: Pre-dose
|
462.486 nanograms/milliliter (ng/mL)
Standard Deviation 180.098
|
1567.692 nanograms/milliliter (ng/mL)
Standard Deviation 557.745
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758- Week 8: Pre-dose
|
474.073 nanograms/milliliter (ng/mL)
Standard Deviation 157.549
|
1432.808 nanograms/milliliter (ng/mL)
Standard Deviation 530.377
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758- Week 12: Pre-dose
|
465.665 nanograms/milliliter (ng/mL)
Standard Deviation 195.227
|
1459.062 nanograms/milliliter (ng/mL)
Standard Deviation 451.013
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA103488- Day 1: 1 hour postdose
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA103488- Day 1: 3 hours postdose
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA103488- Day 1: 6 hours postdose
|
NA nanograms/milliliter (ng/mL)
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
85.832 nanograms/milliliter (ng/mL)
Standard Deviation 257.664
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA103488- Week 1: Pre-dose
|
356.186 nanograms/milliliter (ng/mL)
Standard Deviation 162.209
|
838.907 nanograms/milliliter (ng/mL)
Standard Deviation 255.419
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA103488- Week 2: Pre-dose
|
501.847 nanograms/milliliter (ng/mL)
Standard Deviation 218.467
|
1135.731 nanograms/milliliter (ng/mL)
Standard Deviation 270.004
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA103488- Week 4: Pre-dose
|
536.266 nanograms/milliliter (ng/mL)
Standard Deviation 275.013
|
1191.783 nanograms/milliliter (ng/mL)
Standard Deviation 251.853
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA103488- Week 8: Pre-dose
|
615.740 nanograms/milliliter (ng/mL)
Standard Deviation 229.359
|
1234.708 nanograms/milliliter (ng/mL)
Standard Deviation 201.055
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA101495- Day 1: 1 hour postdose
|
652.136 nanograms/milliliter (ng/mL)
Standard Deviation 354.652
|
2272.257 nanograms/milliliter (ng/mL)
Standard Deviation 1246.128
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA101495- Day 1: 3 hours postdose
|
1691.267 nanograms/milliliter (ng/mL)
Standard Deviation 469.766
|
4176.000 nanograms/milliliter (ng/mL)
Standard Deviation 1211.166
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA101495- Day 1: 6 hours postdose
|
1925.357 nanograms/milliliter (ng/mL)
Standard Deviation 330.335
|
4636.000 nanograms/milliliter (ng/mL)
Standard Deviation 809.804
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA101495- Week 1: Pre-dose
|
4571.214 nanograms/milliliter (ng/mL)
Standard Deviation 719.566
|
9223.786 nanograms/milliliter (ng/mL)
Standard Deviation 2365.168
|
—
|
|
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA103488- Week 12: Pre-dose
|
621.813 nanograms/milliliter (ng/mL)
Standard Deviation 241.354
|
1307.492 nanograms/milliliter (ng/mL)
Standard Deviation 331.553
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 3 and 6 hours postdose on Day 1Population: The PK Population included all participants in mITT population who had at least 1 evaluable PK assessment. 1 Participant (who was randomized to Placebo) mistakenly received Zilucoplan on Day 1 following a dispensing error (which was documented as a minor PD). Due to data confidentiality reasons, the results have not been reported for the placebo arm.
Cmax is defined as the maximum observed plasma concentration.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Maximum Plasma Concentration (Cmax) on Day 1
|
1945.467 ng/mL
Standard Deviation 407.273
|
4858.643 ng/mL
Standard Deviation 1004.457
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 3 and 6 hours postdose on Day 1Population: The PK Population included all participants in mITT population who had at least 1 evaluable PK assessment. 1 Participant (who was randomized to Placebo) mistakenly received Zilucoplan on Day 1 following a dispensing error (which was documented as a minor PD). Due to data confidentiality reasons, the results have not been reported for the placebo arm.
Tmax is defined as the time to observe maximum plasma concentration.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Time Corresponding to Cmax (Tmax) on Day 1
|
4.550 hours
Interval 2.95 to 5.5
|
4.700 hours
Interval 2.62 to 5.92
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 3 and 6 hours postdose on Day 1; Pre-dose on Week 1, 2, 4, 8 and 12Population: The PK Population included all participants in mITT population who had at least 1 evaluable PK assessment. Here "Number Analyzed" signifies number of participants who were evaluable at specified time points. 1 Participant (who was randomized to Placebo) mistakenly received Zilucoplan on Day 1 following a dispensing error (which was documented as a minor PD). Due to data confidentiality reasons, the results have not been reported for the placebo arm.
RA102758 and RA103488 are the metabolites of RA101495.
Outcome measures
| Measure |
RA101495 0.1 mg/kg (mITT)
n=15 Participants
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
RA101495 0.3 mg/kg (mITT)
n=14 Participants
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
Placebo (mITT)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
|
|---|---|---|---|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Day 1: 6 hours postdose
|
0.000 ratio
Standard Deviation 0.000
|
0.015 ratio
Standard Deviation 0.045
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Week 1: Pre-dose
|
0.079 ratio
Standard Deviation 0.037
|
0.099 ratio
Standard Deviation 0.044
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Week 2: Pre-dose
|
0.104 ratio
Standard Deviation 0.044
|
0.114 ratio
Standard Deviation 0.037
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Week 4: Pre-dose
|
0.106 ratio
Standard Deviation 0.046
|
0.119 ratio
Standard Deviation 0.038
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Week 8: Pre-dose
|
0.118 ratio
Standard Deviation 0.044
|
0.127 ratio
Standard Deviation 0.040
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Week 12: Pre-dose
|
0.116 ratio
Standard Deviation 0.035
|
0.131 ratio
Standard Deviation 0.041
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Week 2: Pre-dose
|
0.182 ratio
Standard Deviation 0.038
|
0.307 ratio
Standard Deviation 0.057
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Week 4: Pre-dose
|
0.197 ratio
Standard Deviation 0.072
|
0.323 ratio
Standard Deviation 0.072
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Week 8: Pre-dose
|
0.195 ratio
Standard Deviation 0.057
|
0.301 ratio
Standard Deviation 0.070
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Week 12: Pre-dose
|
0.184 ratio
Standard Deviation 0.065
|
0.303 ratio
Standard Deviation 0.061
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Day 1: Pre-dose
|
NA ratio
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
NA ratio
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Day 1: 1 hour postdose
|
0.000 ratio
Standard Deviation 0.000
|
0.000 ratio
Standard Deviation 0.000
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA103488/RA101495- Day 1: 3 hours postdose
|
0.000 ratio
Standard Deviation 0.000
|
0.001 ratio
Standard Deviation 0.001
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Day 1: Pre-dose
|
NA ratio
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
NA ratio
Standard Deviation NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Day 1: 1 hour postdose
|
0.000 ratio
Standard Deviation 0.000
|
0.000 ratio
Standard Deviation 0.000
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Day 1: 3 hours postdose
|
0.000 ratio
Standard Deviation 0.000
|
0.000 ratio
Standard Deviation 0.000
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Day 1: 6 hours postdose
|
0.000 ratio
Standard Deviation 0.000
|
0.013 ratio
Standard Deviation 0.044
|
—
|
|
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758/RA101495- Week 1: Pre-dose
|
0.121 ratio
Standard Deviation 0.033
|
0.202 ratio
Standard Deviation 0.038
|
—
|
Adverse Events
Main Portion: RA101495 0.1 mg/kg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Main Portion: RA101495 0.3 mg/kg
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Main Portion: Placebo
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Main and Extension Portion: RA101495 0.1 mg/kg Before Switch to 0.3 mg/kg
Serious events: 5 serious events
Other events: 22 other events
Deaths: 1 deaths
Main and Extension Portion: RA101495 0.1 mg/kg After Switch to 0.3 mg/kg
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Main and Extension Portion: RA101495 0.3 mg/kg
Serious events: 11 serious events
Other events: 21 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Main Portion: RA101495 0.1 mg/kg
n=15 participants at risk
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion.
|
Main Portion: RA101495 0.3 mg/kg
n=14 participants at risk
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion
|
Main Portion: Placebo
n=15 participants at risk
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion.
|
Main and Extension Portion: RA101495 0.1 mg/kg Before Switch to 0.3 mg/kg
n=22 participants at risk
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion.
|
Main and Extension Portion: RA101495 0.1 mg/kg After Switch to 0.3 mg/kg
n=21 participants at risk
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to Week 48 (until protocol amendment v3.0). Following implementation of protocol amendment v3.0, and upon appropriate reconsent, all study participants ongoing in the extension portion who had previously received the RA101495 0.1mg/kg/day dose switched to receive the RA101495 0.3mg/kg/day until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
Main and Extension Portion: RA101495 0.3 mg/kg
n=21 participants at risk
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Worsening of Myasthenia Gravis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
20.0%
3/15 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Investigations
Blood culture positive
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Postoperative hypertension
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Rapidly progressive osteoarthritis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
Other adverse events
| Measure |
Main Portion: RA101495 0.1 mg/kg
n=15 participants at risk
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion.
|
Main Portion: RA101495 0.3 mg/kg
n=14 participants at risk
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion
|
Main Portion: Placebo
n=15 participants at risk
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion.
|
Main and Extension Portion: RA101495 0.1 mg/kg Before Switch to 0.3 mg/kg
n=22 participants at risk
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion.
|
Main and Extension Portion: RA101495 0.1 mg/kg After Switch to 0.3 mg/kg
n=21 participants at risk
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to Week 48 (until protocol amendment v3.0). Following implementation of protocol amendment v3.0, and upon appropriate reconsent, all study participants ongoing in the extension portion who had previously received the RA101495 0.1mg/kg/day dose switched to receive the RA101495 0.3mg/kg/day until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
Main and Extension Portion: RA101495 0.3 mg/kg
n=21 participants at risk
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Pain
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Injection site pain
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
27.3%
6/22 • Number of events 9 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
23.8%
5/21 • Number of events 6 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
38.1%
8/21 • Number of events 8 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.6%
3/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
19.0%
4/21 • Number of events 5 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.6%
3/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
19.0%
4/21 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
19.0%
4/21 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
23.8%
5/21 • Number of events 6 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 5 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Headache
|
40.0%
6/15 • Number of events 6 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
21.4%
3/14 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
26.7%
4/15 • Number of events 5 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
45.5%
10/22 • Number of events 13 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
19.0%
4/21 • Number of events 10 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
26.7%
4/15 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
18.2%
4/22 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
18.2%
4/22 • Number of events 7 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
23.8%
5/21 • Number of events 8 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
23.8%
5/21 • Number of events 6 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Injection site bruising
|
13.3%
2/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.3%
2/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
27.3%
6/22 • Number of events 13 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Injection site scab
|
20.0%
3/15 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.6%
3/22 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Injection site nodule
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.6%
3/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
23.8%
5/21 • Number of events 7 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.3%
2/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
2/14 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 8 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Investigations
Amylase increased
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
2/14 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Investigations
Lipase increased
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.3%
2/15 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Eye disorders
Cataract
|
6.7%
1/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Worsening of Myasthenia Gravis
|
13.3%
2/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.3%
2/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
18.2%
4/22 • Number of events 6 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
3/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.3%
2/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.6%
3/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Localised infection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 4 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Nervous system disorders
Tremor
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
13.3%
2/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Gastrointestinal disorders
Lip dry
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Injection site discomfort
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Peripheral swelling
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
General disorders
Swelling face
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Animal bite
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Investigations
Weight decreased
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.1%
2/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Vascular disorders
Hot flush
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Vascular disorders
Cyanosis
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Vascular disorders
Peripheral venous disease
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Eye disorders
Eyelid ptosis
|
6.7%
1/15 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/14 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.5%
1/22 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
4.8%
1/21 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 3 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
14.3%
2/14 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
7.1%
1/14 • Number of events 1 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/15 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/22 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
0.00%
0/21 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
9.5%
2/21 • Number of events 2 • From Baseline up to Week 122
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60