Trial Outcomes & Findings for Long-Term Evaluation of BIIB067 (Tofersen) (NCT NCT03070119)
NCT ID: NCT03070119
Last Updated: 2025-08-29
Results Overview
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly. TEAEs were defined as any AEs or SAE with an onset date and time that was on or after the first dose of study drug, or any pre-existing condition that worsened in severity after the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
139 participants
Primary outcome timeframe
From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
Results posted on
2025-08-29
Participant Flow
Participants were enrolled and took part at the investigative sites in Belgium, Canada, France, Germany, Italy, Japan, Denmark, the United Kingdom, and the United States from 08 Mar 2017 to 12 Aug 2024.
A total of 139 participants were randomized in the study, of which 95 participants rolled over from Part C and 44 participants rolled over from Parts A and B of the parent study 233AS101 (NCT02623699).
Participant milestones
| Measure |
233AS101: Part C (Prior Placebo)
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100 milligrams (mg), once every 2 weeks (Q2W), on Days 1, 15, and 29 by intrathecal (IT) bolus injection in this study followed by up to 90 maintenance doses of BIIB067, every 4 weeks (Q4W), until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
63
|
44
|
|
Overall Study
COMPLETED
|
12
|
34
|
26
|
|
Overall Study
NOT COMPLETED
|
20
|
29
|
18
|
Reasons for withdrawal
| Measure |
233AS101: Part C (Prior Placebo)
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100 milligrams (mg), once every 2 weeks (Q2W), on Days 1, 15, and 29 by intrathecal (IT) bolus injection in this study followed by up to 90 maintenance doses of BIIB067, every 4 weeks (Q4W), until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Consent Withdrawn
|
6
|
5
|
3
|
|
Overall Study
Investigator Decision
|
0
|
0
|
1
|
|
Overall Study
Death
|
7
|
14
|
5
|
|
Overall Study
Disease Progression
|
5
|
7
|
7
|
|
Overall Study
Reason not Specified
|
2
|
2
|
1
|
Baseline Characteristics
Long-Term Evaluation of BIIB067 (Tofersen)
Baseline characteristics by cohort
| Measure |
233AS101: Part C (Prior Placebo)
n=32 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=63 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
n=44 Participants
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 11.00 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 11.80 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 11.04 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 11.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
22 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
6 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)Population: The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly. TEAEs were defined as any AEs or SAE with an onset date and time that was on or after the first dose of study drug, or any pre-existing condition that worsened in severity after the first dose of study drug.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=32 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=63 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
n=44 Participants
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)
TEAEs
|
31 Participants
|
63 Participants
|
43 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)
TESAEs
|
16 Participants
|
33 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: As planned, plasma concentration of BIIB067 was summarized for 233AS101 Part C participants only. Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment \& had at least 1 post-dosing PK concentration measurement in current study. 'Overall number of participants analyzed' indicates the number of participants evaluable for this outcome measure at specified time point.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=28 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=60 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
Plasma Concentration of BIIB067
|
1.22 nanograms per milliliter (ng/mL)
Standard Error 0.118
|
2.05 nanograms per milliliter (ng/mL)
Standard Error 0.516
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: As planned, concentration of BIIB067 in CSF was summarized for 233AS101 Part C participants only. PK population included all participants who received at least 1 dose of study treatment \& had at least 1 post-dosing PK concentration measurement in current study. 'Overall number of participants analyzed' indicates the number of participants evaluable for this outcome measure at specified time point.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=25 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=47 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
Concentration of BIIB067 in Cerebrospinal Fluid (CSF)
|
19.35 ng/mL
Standard Error 2.829
|
9.18 ng/mL
Standard Error 0.711
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 148Population: Integrated analysis was performed on overall ITT population which included all Part C participants of 233AS101 and participants who rolled over from 233AS101 Part C into 233AS102. 'Overall number of participants analyzed' exceeds the total number of participants who started study 233AS102 as it indicates participants who were randomized in the Part C 233AS101 study. Number analyzed 'n' indicates the number of participants evaluable for this outcome measure at specified time point.
This outcome measure was not a standalone analysis for 233AS102. Analysis was performed on the data collected from both 233AS101 and 233AS102 studies. This is reported as a part of the final integrated analyses. Baseline is defined as the Day 1 of 233AS101 Part C. Data has been reported for Weeks 52, 104 and 148 from the 233AS101 Part C baseline.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=36 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=72 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
233AS101 and 233AS102 Integrated Summary of Efficacy (ISE): Total CSF Superoxide Dismutase 1 (SOD1) Protein Ratio to Baseline
Week 52
|
0.78 ratio
Interval 0.64 to 0.96
|
0.67 ratio
Interval 0.57 to 0.79
|
—
|
|
233AS101 and 233AS102 Integrated Summary of Efficacy (ISE): Total CSF Superoxide Dismutase 1 (SOD1) Protein Ratio to Baseline
Week 104
|
0.81 ratio
Interval 0.67 to 0.97
|
0.74 ratio
Interval 0.65 to 0.84
|
—
|
|
233AS101 and 233AS102 Integrated Summary of Efficacy (ISE): Total CSF Superoxide Dismutase 1 (SOD1) Protein Ratio to Baseline
Week 148
|
0.75 ratio
Interval 0.61 to 0.92
|
0.79 ratio
Interval 0.69 to 0.91
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 148Population: Integrated analysis was performed on overall ITT population which included all Part C participants of 233AS101 and participants who rolled over from 233AS101 Part C into 233AS102. 'Overall number of participants analyzed' exceeds the total number of participants who started study 233AS102 as it indicates participants who were randomized in the Part C 233AS101 study. Number analyzed 'n' indicates the number of participants evaluable for this outcome measure at specified time point.
This outcome measure was not a standalone analysis for 233AS102. Analysis was performed on the data collected from both 233AS101 and 233AS102 studies. This is reported as a part of the final integrated analyses. Baseline is defined as the Day 1 of 233AS101 Part C. Data has been reported for Weeks 52, 104 and 148 from the 233AS101 Part C baseline.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=36 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=72 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
233AS101 and 233AS102 ISE: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline
Week 52
|
0.62 ratio
Interval 0.49 to 0.78
|
0.50 ratio
Interval 0.42 to 0.6
|
—
|
|
233AS101 and 233AS102 ISE: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline
Week 104
|
0.41 ratio
Interval 0.3 to 0.55
|
0.33 ratio
Interval 0.27 to 0.42
|
—
|
|
233AS101 and 233AS102 ISE: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline
Week 148
|
0.36 ratio
Interval 0.25 to 0.53
|
0.33 ratio
Interval 0.26 to 0.43
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 148Population: Integrated analysis was performed on overall ITT population which included all Part C participants of 233AS101 and participants who rolled over from 233AS101 Part C into 233AS102. 'Overall number of participants analyzed' exceeds the total number of participants who started study 233AS102 as it indicates participants who were randomized in the Part C 233AS101 study. Number analyzed 'n' indicates the number of participants evaluable for this outcome measure at specified time point.
The ALSFRS-R measures 4 functional domains, including respiratory, bulbar function, gross motor skills, and fine motor skills. There are 12 questions, each scored from 0 (no function) to 4 (full function). The ALSFRS-R total score was calculated as the sum of the 4 functional domain scores, ranging from 0 to 48, where higher scores representing better function. Negative change from baseline indicates disease progression. This outcome measure was not a standalone analysis for 233AS102. Analysis was performed on the data collected from both 233AS101 and 233AS102 studies. This is reported as a part of the final integrated analyses. Baseline is defined as the Day 1 of 233AS101 Part C. Data has been reported for Weeks 52, 104 and 148 from the 233AS101 Part C baseline.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=36 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=72 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
233AS101 and 233AS102 ISE: Change From Baseline in Total Amyotropic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score
Week 52
|
-9.5 score on a scale
Standard Error 1.46
|
-5.9 score on a scale
Standard Error 1.16
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Total Amyotropic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score
Week 104
|
-13.1 score on a scale
Standard Error 2.12
|
-9.4 score on a scale
Standard Error 1.69
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Total Amyotropic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score
Week 148
|
-13.5 score on a scale
Standard Error 2.28
|
-9.9 score on a scale
Standard Error 1.77
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 148Population: Integrated analysis was performed on overall ITT population which included all Part C participants of 233AS101 and participants who rolled over from 233AS101 Part C into 233AS102. 'Overall number of participants analyzed' exceeds the total number of participants who started study 233AS102 as it indicates participants who were randomized in the Part C 233AS101 study. Number analyzed 'n' indicates the number of participants evaluable for this outcome measure at specified time point.
Vital capacity was measured by means of an SVC test, administered in the upright position. Upright SVC was determined by performing 3 to 5 measures, in accordance with criteria established by the American Thoracic Society and the European Respiratory Society. The percent predicted SVC was calculated as \[observed SVC divided by predicted SVC\]\*100%. The predicted SVC was adjusted by sex, age, height, which was programmed into and performed by the equipment used. Negative change from baseline indicated worsening of respiratory capacity. This outcome measure was not a standalone analysis for 233AS102. Analysis was performed on the data collected from both 233AS101 and 233AS102 studies. This is reported as a part of the final integrated analyses. Baseline is defined as the Day 1 of 233AS101 Part C. Data has been reported for Weeks 52, 104 and 148 from the 233AS101 Part C baseline.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=36 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=72 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
233AS101 and 233AS102 ISE: Change From Baseline in Percent Predicted Slow Vital Capacity (SVC)
Week 52
|
-18.7 percentage of predicted volume
Standard Error 3.70
|
-10.6 percentage of predicted volume
Standard Error 2.99
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Percent Predicted Slow Vital Capacity (SVC)
Week 104
|
-23.7 percentage of predicted volume
Standard Error 5.90
|
-14.4 percentage of predicted volume
Standard Error 4.46
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Percent Predicted Slow Vital Capacity (SVC)
Week 148
|
-18.1 percentage of predicted volume
Standard Error 5.74
|
-13.8 percentage of predicted volume
Standard Error 4.07
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 148Population: Integrated analysis was performed on overall ITT population which included all Part C participants of 233AS101 and participants who rolled over from 233AS101 Part C into 233AS102. 'Overall number of participants analyzed' exceeds the total number of participants who started study 233AS102 as it indicates participants who were randomized in the Part C 233AS101 study. Number analyzed 'n' indicates the number of participants evaluable for this outcome measure at specified time point.
Quantitative muscle strength was evaluated using the HHD Megascore, which tests isometric strength of multiple muscles using standard participant positioning. Approximately 8 muscle groups were examined (per each side) in both upper and lower extremities. The muscle strength values were normalized to Z scores as (post-baseline measurements - mean)/SD and averaged to provide HHD overall megascore. The overall megascore was created by averaging all eight bilateral measurement Z scores, if no more than 10 (≤ 10) measures are missing. A negative change from baseline indicated decreased muscle strength. This outcome measure was not a standalone analysis for 233AS102. Analysis was performed on the data collected from both 233AS101 and 233AS102 studies. This is reported as a part of the final integrated analyses. Baseline is defined as the Day 1 of 233AS101 Part C. Data has been reported for Weeks 52, 104 and 148 from the 233AS101 Part C baseline.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=36 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=72 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
233AS101 and 233AS102 ISE: Change From Baseline in Handheld Dynamometry (HHD) Overall Megascore
Week 52
|
-0.41 score on a scale
Standard Error 0.101
|
-0.15 score on a scale
Standard Error 0.079
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Handheld Dynamometry (HHD) Overall Megascore
Week 104
|
-0.56 score on a scale
Standard Error 0.154
|
-0.42 score on a scale
Standard Error 0.112
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Handheld Dynamometry (HHD) Overall Megascore
Week 148
|
-0.43 score on a scale
Standard Error 0.089
|
-0.38 score on a scale
Standard Error 0.062
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 148Population: Integrated analysis was performed on overall ITT population which included all Part C participants of 233AS101 and participants who rolled over from 233AS101 Part C into 233AS102. 'Overall number of participants analyzed' exceeds the total number of participants who started study 233AS102 as it indicates participants who were randomized in the Part C 233AS101 study. Number analyzed 'n' indicates the number of participants evaluable for this outcome measure at specified time point.
Individual muscle strength was evaluated using handheld dynamometer which tests the isometric strength of multiple muscles using standard participant positioning. Eight muscle groups were examined (per each side) in both upper and lower extremities. Negative change from baseline=decreased muscle strength. The analyses was based on observed data. This outcome measure was not a standalone analysis for 233AS102. Analysis was performed on data collected from both 233AS101 \& 233AS102 studies. This is reported as a part of final integrated analyses.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=36 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=72 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Shoulder Flexion: Week 52
|
-3.42 kilogram (kg)
Standard Deviation 6.671
|
-0.51 kilogram (kg)
Standard Deviation 8.484
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Shoulder Flexion: Week 104
|
0.17 kilogram (kg)
Standard Deviation 5.714
|
-4.16 kilogram (kg)
Standard Deviation 14.329
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Shoulder Flexion: Week 148
|
-2.48 kilogram (kg)
Standard Deviation 5.075
|
-4.12 kilogram (kg)
Standard Deviation 8.543
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Elbow Flexion: Week 52
|
-3.89 kilogram (kg)
Standard Deviation 6.747
|
-0.24 kilogram (kg)
Standard Deviation 8.031
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Elbow Flexion: Week 104
|
-1.26 kilogram (kg)
Standard Deviation 7.361
|
-3.12 kilogram (kg)
Standard Deviation 13.334
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Elbow Flexion: Week 148
|
0.65 kilogram (kg)
Standard Deviation 4.560
|
-3.33 kilogram (kg)
Standard Deviation 8.753
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Wrist Extension: Week 52
|
-3.66 kilogram (kg)
Standard Deviation 4.775
|
-0.41 kilogram (kg)
Standard Deviation 7.170
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Wrist Extension: Week 104
|
-0.86 kilogram (kg)
Standard Deviation 5.279
|
-1.74 kilogram (kg)
Standard Deviation 8.517
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Wrist Extension: Week 148
|
0.95 kilogram (kg)
Standard Deviation 5.242
|
-2.49 kilogram (kg)
Standard Deviation 6.086
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction Index Finger (First Dorsal Interosseous): Week 52
|
-0.96 kilogram (kg)
Standard Deviation 1.450
|
-0.93 kilogram (kg)
Standard Deviation 4.448
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction Index Finger (First Dorsal Interosseous): Week 104
|
-0.63 kilogram (kg)
Standard Deviation 1.266
|
-0.62 kilogram (kg)
Standard Deviation 2.279
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction Index Finger (First Dorsal Interosseous): Week 148
|
-0.41 kilogram (kg)
Standard Deviation 1.604
|
-1.28 kilogram (kg)
Standard Deviation 4.913
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction Thumb (Abductor Pollicus Brevis): Week 52
|
-1.15 kilogram (kg)
Standard Deviation 1.486
|
-0.70 kilogram (kg)
Standard Deviation 2.497
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction Thumb (Abductor Pollicus Brevis): Week 104
|
-0.69 kilogram (kg)
Standard Deviation 1.089
|
-0.19 kilogram (kg)
Standard Deviation 2.382
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction Thumb (Abductor Pollicus Brevis): Week 148
|
-1.10 kilogram (kg)
Standard Deviation 2.324
|
-0.78 kilogram (kg)
Standard Deviation 3.049
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction 5th Digit (Abductor Digiti Minimi): Week 52
|
-0.66 kilogram (kg)
Standard Deviation 1.208
|
-0.49 kilogram (kg)
Standard Deviation 2.296
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction 5th Digit (Abductor Digiti Minimi): Week 104
|
-0.47 kilogram (kg)
Standard Deviation 1.226
|
-0.50 kilogram (kg)
Standard Deviation 1.999
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Abduction 5th Digit (Abductor Digiti Minimi): Week 148
|
-0.43 kilogram (kg)
Standard Deviation 1.496
|
-0.66 kilogram (kg)
Standard Deviation 2.394
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Knee Extension: Week 52
|
-4.94 kilogram (kg)
Standard Deviation 8.015
|
1.80 kilogram (kg)
Standard Deviation 10.744
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Knee Extension: Week 104
|
-2.41 kilogram (kg)
Standard Deviation 6.545
|
-1.54 kilogram (kg)
Standard Deviation 13.222
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Knee Extension: Week 148
|
-2.48 kilogram (kg)
Standard Deviation 7.339
|
-2.01 kilogram (kg)
Standard Deviation 9.711
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Ankle Dorsiflexion: Week 52
|
-2.82 kilogram (kg)
Standard Deviation 7.560
|
0.72 kilogram (kg)
Standard Deviation 7.701
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Ankle Dorsiflexion: Week 104
|
-5.47 kilogram (kg)
Standard Deviation 3.590
|
-4.20 kilogram (kg)
Standard Deviation 11.516
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Left Ankle Dorsiflexion: Week 148
|
-5.43 kilogram (kg)
Standard Deviation 5.303
|
-2.33 kilogram (kg)
Standard Deviation 9.533
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Shoulder Flexion: Week 52
|
-4.74 kilogram (kg)
Standard Deviation 5.494
|
-0.96 kilogram (kg)
Standard Deviation 5.728
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Shoulder Flexion: Week 104
|
-2.72 kilogram (kg)
Standard Deviation 4.638
|
-2.81 kilogram (kg)
Standard Deviation 9.304
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Shoulder Flexion: Week 148
|
-3.02 kilogram (kg)
Standard Deviation 5.066
|
-3.18 kilogram (kg)
Standard Deviation 8.139
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Elbow Flexion: Week 52
|
-4.03 kilogram (kg)
Standard Deviation 5.663
|
-1.20 kilogram (kg)
Standard Deviation 7.015
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Elbow Flexion: Week 104
|
-1.32 kilogram (kg)
Standard Deviation 6.289
|
-3.04 kilogram (kg)
Standard Deviation 9.717
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Elbow Flexion: Week 148
|
0.49 kilogram (kg)
Standard Deviation 3.407
|
-3.28 kilogram (kg)
Standard Deviation 8.704
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Wrist Extension: Week 52
|
-3.82 kilogram (kg)
Standard Deviation 5.892
|
-0.63 kilogram (kg)
Standard Deviation 4.870
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Wrist Extension: Week 104
|
-0.76 kilogram (kg)
Standard Deviation 4.086
|
-1.65 kilogram (kg)
Standard Deviation 6.267
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Wrist Extension: Week 148
|
0.09 kilogram (kg)
Standard Deviation 5.096
|
-1.89 kilogram (kg)
Standard Deviation 5.033
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction Index Finger (First Dorsal Interosseous): Week 52
|
-0.86 kilogram (kg)
Standard Deviation 1.381
|
-0.36 kilogram (kg)
Standard Deviation 1.405
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction Index Finger (First Dorsal Interosseous): Week 104
|
-0.38 kilogram (kg)
Standard Deviation 1.057
|
-0.45 kilogram (kg)
Standard Deviation 1.569
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction Index Finger (First Dorsal Interosseous): Week 148
|
-0.23 kilogram (kg)
Standard Deviation 1.545
|
-0.46 kilogram (kg)
Standard Deviation 1.193
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction Thumb (Abductor Pollicus Brevis): Week 52
|
-0.98 kilogram (kg)
Standard Deviation 1.425
|
-1.24 kilogram (kg)
Standard Deviation 4.595
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction Thumb (Abductor Pollicus Brevis): Week 104
|
-0.31 kilogram (kg)
Standard Deviation 0.947
|
-0.24 kilogram (kg)
Standard Deviation 2.016
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction Thumb (Abductor Pollicus Brevis): Week 148
|
-0.86 kilogram (kg)
Standard Deviation 1.861
|
-1.10 kilogram (kg)
Standard Deviation 5.247
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction 5th Digit (Abductor Digiti Minimi): Week 52
|
-0.78 kilogram (kg)
Standard Deviation 1.210
|
-1.12 kilogram (kg)
Standard Deviation 5.112
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction 5th Digit (Abductor Digiti Minimi): Week 104
|
-0.54 kilogram (kg)
Standard Deviation 1.059
|
-0.21 kilogram (kg)
Standard Deviation 1.639
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Abduction 5th Digit (Abductor Digiti Minimi): Week 148
|
-0.69 kilogram (kg)
Standard Deviation 1.009
|
-1.36 kilogram (kg)
Standard Deviation 5.634
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Knee Extension: Week 52
|
-4.90 kilogram (kg)
Standard Deviation 5.964
|
1.05 kilogram (kg)
Standard Deviation 8.973
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Knee Extension: Week 104
|
-2.16 kilogram (kg)
Standard Deviation 9.453
|
-3.09 kilogram (kg)
Standard Deviation 13.046
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Knee Extension: Week 148
|
-0.19 kilogram (kg)
Standard Deviation 7.407
|
-1.60 kilogram (kg)
Standard Deviation 7.685
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Ankle Dorsiflexion: Week 52
|
-5.68 kilogram (kg)
Standard Deviation 8.907
|
-1.05 kilogram (kg)
Standard Deviation 5.923
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Ankle Dorsiflexion: Week 104
|
-5.86 kilogram (kg)
Standard Deviation 3.501
|
-3.78 kilogram (kg)
Standard Deviation 13.008
|
—
|
|
233AS101 and 233AS102 ISE: Change From Baseline in Individual Muscle Strength Assessed by HHD
Right Ankle Dorsiflexion: Week 148
|
-6.74 kilogram (kg)
Standard Deviation 7.308
|
-3.40 kilogram (kg)
Standard Deviation 8.172
|
—
|
SECONDARY outcome
Timeframe: From the baseline of the study 233AS101 up to the end of the follow-up period of the current study (up to Week 364)Population: Integrated analysis was performed on overall ITT population which included all Part C participants of 233AS101 and participants who rolled over from 233AS101 Part C into 233AS102. 'Overall number of participants analyzed' exceeds the total number of participants who started study 233AS102 as it indicates participants who were randomized in the Part C 233AS101 study.
Permanent ventilation was defined as ≥ 22 hours of mechanical ventilation \[invasive or noninvasive\] per day for ≥ 21 consecutive days. An event of permanent ventilation was based on an adjudicated event (i.e., adjudicated by the Endpoint Adjudication Committee (EAC) as having met the permanent ventilation criteria defined in the protocol). Time to death or permanent ventilation was defined as the time to the earliest occurrence of death or permanent ventilation. The start date for calculating time to death or permanent ventilation in days was date of first dose. Participants without an event were censored at the last known alive dates. This outcome measure was not a standalone analysis for 233AS102. Analysis was performed on data collected from both 233AS101 \& 233AS102 studies. This is reported as a part of final integrated analyses. Time to permanent ventilation or death was summarized using the Kaplan-Meier product limit method.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=36 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=72 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
233AS101 and 233AS102 ISE: Time to Death or Permanent Ventilation
|
NA weeks
Interval 135.6 to
Due to the low number of events, the median and upper range of the 95% confidence interval (CI) were not estimable.
|
NA weeks
Interval 253.6 to
Due to the low number of events, the median and upper range of the 95% CI were not estimable.
|
—
|
SECONDARY outcome
Timeframe: From the baseline of the study 233AS101 up to the end of the follow-up period of the current study (up to Week 364)Population: Integrated analysis was performed on overall ITT population which included all Part C participants of 233AS101 and participants who rolled over from 233AS101 Part C into 233AS102. 'Overall number of participants analyzed' exceeds the total number of participants who started study 233AS102 as it indicates participants who were randomized in the Part C 233AS101 study.
Time to death was defined as the time from first dose received in 233AS101 to death. Participants who do not meet the endpoint definition were censored at the participant's last known alive date. Only events that were adjudicated by the EAC are included. This outcome measure was not a standalone analysis for 233AS102. Analysis was performed on data collected from both 233AS101 \& 233AS102 studies. This is reported as a part of final integrated analyses. Time to death was summarized using the Kaplan-Meier product limit method.
Outcome measures
| Measure |
233AS101: Part C (Prior Placebo)
n=36 Participants
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=72 Participants
Participants who were randomized to BIIB067 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg, on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067,Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
233AS101: Part A and B (All Doses)
Participants who were randomized to BIIB067 or placebo in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40 mg, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 20 mg, 40 mg, 60 mg, or 100 mg, eventually escalated to 100 mg, 2 weeks apart, and up to 90 maintenance doses, Q4W, by IT bolus injection until the last enrolled participant had their Week 152 maintenance dose visit in this study.
|
|---|---|---|---|
|
233AS101 and 233AS102 ISE: Time to Death
|
NA weeks
Due to the low number of events, the median and the 95% CI were not estimable.
|
NA weeks
Interval 260.7 to
Due to the low number of events, the median and upper range of the 95% CI were not estimable.
|
—
|
Adverse Events
233AS101: Part C (Prior Placebo)
Serious events: 16 serious events
Other events: 31 other events
Deaths: 7 deaths
233AS101: Part C (Prior BIIB067 100 mg)
Serious events: 33 serious events
Other events: 63 other events
Deaths: 14 deaths
233AS101: Parts A and B (All Doses)
Serious events: 22 serious events
Other events: 43 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
233AS101: Part C (Prior Placebo)
n=32 participants at risk
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100 mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last participant enrolled had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=63 participants at risk
Participants who were randomized to BIIB067, 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last participant enrolled had their Week 152 maintenance dose visit.
|
233AS101: Parts A and B (All Doses)
n=44 participants at risk
Participants who were randomized to BIIB067 in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 100 mg, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Eye disorders
Papilloedema
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.1%
7/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Faecaloma
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Large intestine perforation
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Death
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Sudden death
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Covid-19
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
H1n1 influenza
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Meningitis aseptic
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Myelitis
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Peritonitis
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pneumonia aspiration
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
12.7%
8/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pneumonia bacterial
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Sepsis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Septic shock
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Intracranial pressure increased
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Migraine
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Neuromyelitis optica spectrum disorder
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Neurosarcoidosis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Psychiatric disorders
Mental status changes
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Renal and urinary disorders
Ureterolithiasis
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.5%
6/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
18.8%
6/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.5%
6/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Surgical and medical procedures
Euthanasia
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
Other adverse events
| Measure |
233AS101: Part C (Prior Placebo)
n=32 participants at risk
Participants who were randomized to placebo in Part C of the parent study 233AS101 received 3 loading doses of BIIB067, 100 mg, Q2W, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last participant enrolled had their Week 152 maintenance dose visit.
|
233AS101: Part C (Prior BIIB067 100 mg)
n=63 participants at risk
Participants who were randomized to BIIB067, 100 mg in Part C of the parent study 233AS101 received 2 loading doses of BIIB067, 100 mg on Days 1 and 29, and one dose of BIIB067-matched placebo on Day 15 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last participant enrolled had their Week 152 maintenance dose visit.
|
233AS101: Parts A and B (All Doses)
n=44 participants at risk
Participants who were randomized to BIIB067 in Part A (at doses 10 mg, 20 mg, 40 mg and 60 mg) or Part B (at doses 20 mg, 40, 60 mg and 100 mg) of the parent study 233AS101 received 3 loading doses of BIIB067, 100 mg, on Days 1, 15, and 29 by IT bolus injection in this study followed by up to 90 maintenance doses of BIIB067, Q4W, until the last enrolled participant had their Week 152 maintenance dose visit.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Eye disorders
Conjunctivitis allergic
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Eye disorders
Diplopia
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Eye disorders
Dry eye
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Eye disorders
Papilloedema
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Eye disorders
Vision blurred
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
10/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
19.0%
12/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
25.0%
11/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
12/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.1%
7/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
15.9%
7/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.1%
7/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
12.7%
8/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Nausea
|
21.9%
7/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
20.6%
13/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
38.6%
17/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
20.6%
13/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
15.9%
7/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Chills
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Fatigue
|
31.2%
10/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
25.4%
16/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
29.5%
13/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Influenza like illness
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Malaise
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Oedema peripheral
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
13.6%
6/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Pain
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Peripheral swelling
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Pyrexia
|
25.0%
8/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
17.5%
11/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
25.0%
11/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
General disorders
Vaccination site pain
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Immune system disorders
Seasonal allergy
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Bronchitis
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
13.6%
6/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Covid-19
|
21.9%
7/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
41.3%
26/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
29.5%
13/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Cystitis
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Influenza
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Nasopharyngitis
|
18.8%
6/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
17.5%
11/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
45.5%
20/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Oral candidiasis
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pneumonia
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Pneumonia aspiration
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Rhinitis
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Sinusitis
|
12.5%
4/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Suspected covid-19
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.1%
7/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
20.5%
9/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Urinary tract infection
|
15.6%
5/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
12.7%
8/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
27.3%
12/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Viral infection
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Contusion
|
21.9%
7/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
12.7%
8/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
29.5%
13/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Fall
|
56.2%
18/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
39.7%
25/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
63.6%
28/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Head injury
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Neurological procedural complication
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
18.8%
6/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
23.8%
15/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
29.5%
13/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Post procedural pruritus
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
43.8%
14/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
52.4%
33/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
63.6%
28/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
13.6%
6/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Injury, poisoning and procedural complications
Traumatic lumbar puncture
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Blood glucose increased
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Blood urine present
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Csf glucose increased
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Csf protein increased
|
21.9%
7/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
23.8%
15/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
34.1%
15/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Csf white blood cell count increased
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
23.8%
15/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
25.0%
11/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
Oxygen saturation decreased
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Investigations
White blood cell count increased
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
12/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
30.2%
19/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
38.6%
17/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
43.8%
14/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
42.9%
27/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
59.1%
26/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
8/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
17.5%
11/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
25.0%
11/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
15.6%
5/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
15.9%
10/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
15.9%
7/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
13.6%
6/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
4/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
22.2%
14/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
27.3%
12/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
13.6%
6/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
37.5%
12/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
27.0%
17/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
43.2%
19/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Balance disorder
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Burning sensation
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
20.6%
13/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
29.5%
13/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Dysarthria
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Headache
|
53.1%
17/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
55.6%
35/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
70.5%
31/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
4/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Intracranial pressure increased
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Migraine
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Muscle contractions involuntary
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.5%
6/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Muscle spasticity
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Paraesthesia
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.1%
7/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Pleocytosis
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
15.9%
7/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Radicular pain
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Sensory disturbance
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Nervous system disorders
Tremor
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.1%
4/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.5%
6/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Psychiatric disorders
Insomnia
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.5%
6/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Renal and urinary disorders
Dysuria
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Renal and urinary disorders
Nephrolithiasis
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Renal and urinary disorders
Pollakiuria
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
3.2%
2/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
13.6%
6/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
3/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
17.5%
11/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
11.4%
5/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
7.9%
5/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
13.6%
6/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.8%
3/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
1.6%
1/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.5%
2/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
2.3%
1/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
9.5%
6/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
13.6%
6/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
2/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
4.8%
3/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
15.9%
7/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
6.3%
4/63 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
0.00%
0/44 • From first dose of the study drug in the current study up to end of follow-up period (up to Week 364)
The safety population included all participants who were enrolled and received at least one dose of study treatment in 233AS102.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER