Trial Outcomes & Findings for Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease (NCT NCT03318523)
NCT ID: NCT03318523
Last Updated: 2022-02-28
Results Overview
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
357 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2022-02-28
Participant Flow
Participants were enrolled at 75 investigational sites from 10 January 2018 to 29 April 2021.
Participants with Parkinson's Disease (PD) were enrolled and randomized to receive placebo or BIIB054 250/1250/3500 milligrams (mg) for Year 1 in Placebo-Controlled (PC) Period. Following Year 1, participants on placebo (delayed start) were re-randomized to receive BIIB054 250/1250/3500 mg dose, and others on BIIB054 in Year 1 continued to receive the same dose until their Week 96 visit.
Participant milestones
| Measure |
PC Period: Placebo
Participants received BIIB054-matching placebo, intravenous (IV) infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 250 mg (Early Start)
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 1250 mg (Early Start)
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 3500 mg (Early Start)
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
DBE Period: Placebo to BIIB054 250 mg (Delayed Start)
Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)
Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)
Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: BIIB054 250 mg (Early Start)
Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 250 mg in the PC period were included in this arm.
|
DBE Period: BIIB054 1250 mg (Early Start)
Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 1250 mg in the PC period were included in this arm.
|
DBE Period: BIIB054 3500 mg (Early Start)
Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 3500 mg in the PC period were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PC Period: Up to Year 1
STARTED
|
100
|
55
|
102
|
100
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Up to Year 1
COMPLETED
|
96
|
53
|
100
|
96
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Up to Year 1
NOT COMPLETED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
STARTED
|
0
|
0
|
0
|
0
|
20
|
37
|
39
|
52
|
100
|
96
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
Number of Participants Dosed
|
0
|
0
|
0
|
0
|
20
|
37
|
39
|
52
|
100
|
94
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
20
|
37
|
39
|
52
|
100
|
96
|
Reasons for withdrawal
| Measure |
PC Period: Placebo
Participants received BIIB054-matching placebo, intravenous (IV) infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 250 mg (Early Start)
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 1250 mg (Early Start)
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 3500 mg (Early Start)
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
DBE Period: Placebo to BIIB054 250 mg (Delayed Start)
Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)
Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)
Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: BIIB054 250 mg (Early Start)
Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 250 mg in the PC period were included in this arm.
|
DBE Period: BIIB054 1250 mg (Early Start)
Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 1250 mg in the PC period were included in this arm.
|
DBE Period: BIIB054 3500 mg (Early Start)
Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 3500 mg in the PC period were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PC Period: Up to Year 1
Adverse Event
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Up to Year 1
Consent Withdrawn
|
3
|
2
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
2
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
Consent Withdrawn
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
3
|
2
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
Investigator Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
17
|
36
|
39
|
48
|
94
|
91
|
|
DBE Period:Year 2 to EOS (Up to 3 Years)
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
3
|
0
|
Baseline Characteristics
ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
Baseline characteristics by cohort
| Measure |
PC Period: Placebo
n=100 Participants
Participants received BIIB054-matching placebo, intravenous (IV) infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 250 mg (Early Start)
n=55 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 1250 mg (Early Start)
n=102 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 3500 mg (Early Start)
n=100 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 8.39 • n=100 Participants
|
61.3 years
STANDARD_DEVIATION 9.24 • n=55 Participants
|
59.2 years
STANDARD_DEVIATION 8.48 • n=102 Participants
|
59.3 years
STANDARD_DEVIATION 9.92 • n=100 Participants
|
60.1 years
STANDARD_DEVIATION 9.01 • n=357 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=100 Participants
|
16 Participants
n=55 Participants
|
29 Participants
n=102 Participants
|
34 Participants
n=100 Participants
|
107 Participants
n=357 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=100 Participants
|
39 Participants
n=55 Participants
|
73 Participants
n=102 Participants
|
66 Participants
n=100 Participants
|
250 Participants
n=357 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=100 Participants
|
1 Participants
n=55 Participants
|
1 Participants
n=102 Participants
|
6 Participants
n=100 Participants
|
11 Participants
n=357 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=100 Participants
|
54 Participants
n=55 Participants
|
101 Participants
n=102 Participants
|
94 Participants
n=100 Participants
|
345 Participants
n=357 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=100 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=357 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=100 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=100 Participants
|
2 Participants
n=357 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=100 Participants
|
0 Participants
n=55 Participants
|
3 Participants
n=102 Participants
|
3 Participants
n=100 Participants
|
6 Participants
n=357 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=100 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=357 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=100 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=357 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=100 Participants
|
53 Participants
n=55 Participants
|
92 Participants
n=102 Participants
|
84 Participants
n=100 Participants
|
325 Participants
n=357 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=100 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=357 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=100 Participants
|
2 Participants
n=55 Participants
|
6 Participants
n=102 Participants
|
11 Participants
n=100 Participants
|
23 Participants
n=357 Participants
|
|
Baseline Movement Disorder Society Sponsored Revision of the Unified PD Rating Scale Total Score
|
31.9 score on a scale
STANDARD_DEVIATION 12.41 • n=100 Participants
|
31.9 score on a scale
STANDARD_DEVIATION 12.25 • n=55 Participants
|
32.9 score on a scale
STANDARD_DEVIATION 12.58 • n=102 Participants
|
32.6 score on a scale
STANDARD_DEVIATION 13.46 • n=100 Participants
|
32.4 score on a scale
STANDARD_DEVIATION 12.69 • n=357 Participants
|
|
Baseline MDS-UPDRS Subpart I Score
|
4.3 score on a scale
STANDARD_DEVIATION 3.50 • n=100 Participants
|
3.3 score on a scale
STANDARD_DEVIATION 2.74 • n=55 Participants
|
4.8 score on a scale
STANDARD_DEVIATION 3.99 • n=102 Participants
|
4.3 score on a scale
STANDARD_DEVIATION 3.60 • n=100 Participants
|
4.3 score on a scale
STANDARD_DEVIATION 3.59 • n=357 Participants
|
|
Baseline MDS-UPDRS Subpart II Score
|
5.4 score on a scale
STANDARD_DEVIATION 3.87 • n=100 Participants
|
5.0 score on a scale
STANDARD_DEVIATION 3.30 • n=55 Participants
|
5.3 score on a scale
STANDARD_DEVIATION 3.66 • n=102 Participants
|
5.5 score on a scale
STANDARD_DEVIATION 4.30 • n=100 Participants
|
5.3 score on a scale
STANDARD_DEVIATION 3.84 • n=357 Participants
|
|
Baseline MDS-UPDRS Subpart III Score
|
22.2 score on a scale
STANDARD_DEVIATION 9.31 • n=100 Participants
|
23.5 score on a scale
STANDARD_DEVIATION 9.38 • n=55 Participants
|
22.8 score on a scale
STANDARD_DEVIATION 8.69 • n=102 Participants
|
22.9 score on a scale
STANDARD_DEVIATION 8.86 • n=100 Participants
|
22.8 score on a scale
STANDARD_DEVIATION 8.99 • n=357 Participants
|
|
Baseline Total Striatum Striatal Binding Ratio (SBR)
|
1.295 striatal binding ratio
STANDARD_DEVIATION 0.3177 • n=100 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.409 striatal binding ratio
STANDARD_DEVIATION 0.3875 • n=55 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.342 striatal binding ratio
STANDARD_DEVIATION 0.3197 • n=102 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.351 striatal binding ratio
STANDARD_DEVIATION 0.3495 • n=99 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.342 striatal binding ratio
STANDARD_DEVIATION 0.3393 • n=356 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
|
Baseline Total Putamen SBR
|
1.255 striatal binding ratio
STANDARD_DEVIATION 0.3429 • n=100 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.388 striatal binding ratio
STANDARD_DEVIATION 0.4294 • n=55 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.291 striatal binding ratio
STANDARD_DEVIATION 0.3269 • n=102 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.286 striatal binding ratio
STANDARD_DEVIATION 0.3627 • n=99 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.295 striatal binding ratio
STANDARD_DEVIATION 0.3597 • n=356 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
|
Baseline Total Caudate SBR
|
1.336 striatal binding ratio
STANDARD_DEVIATION 0.3279 • n=100 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.433 striatal binding ratio
STANDARD_DEVIATION 0.3751 • n=55 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.397 striatal binding ratio
STANDARD_DEVIATION 0.3417 • n=102 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.416 striatal binding ratio
STANDARD_DEVIATION 0.3643 • n=99 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
1.391 striatal binding ratio
STANDARD_DEVIATION 0.3501 • n=356 Participants • ITT population. Number analyzed is the number of participants analyzed for this study specific baseline measure.
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). Number of participants analyzed were participants analyzed for this outcome measure.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=29 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=57 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=51 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=53 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52
|
10.48 score on a scale
Standard Error 1.951
|
11.29 score on a scale
Standard Error 1.446
|
10.86 score on a scale
Standard Error 1.518
|
10.78 score on a scale
Standard Error 1.490
|
PRIMARY outcome
Timeframe: Baseline, Week 72Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from Placebo/BIIB054 250/1250/3500 mg for the analysis of this outcome measure. Number of participants analyzed were participants analyzed for this outcome measure.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=32 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=62 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=64 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=68 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72
|
6.83 score on a scale
Standard Error 2.032
|
8.66 score on a scale
Standard Error 1.496
|
6.94 score on a scale
Standard Error 1.508
|
7.11 score on a scale
Standard Error 1.476
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The safety population was defined as all participants who received at least one dose of study treatment (BIIB054).
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; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=55 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=102 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=100 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=96 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
85.5 percentage of participants
|
89.2 percentage of participants
|
93.0 percentage of participants
|
77.1 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
10.9 percentage of participants
|
8.8 percentage of participants
|
12.0 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from Placebo/BIIB054 250/1250/3500 mg for the analysis of this outcome measure. Number of participants analyzed were participants analyzed for this outcome measure.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=28 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=62 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=59 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=67 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96
|
8.28 score on a scale
Standard Error 2.317
|
8.71 score on a scale
Standard Error 1.628
|
8.87 score on a scale
Standard Error 1.659
|
7.88 score on a scale
Standard Error 1.616
|
SECONDARY outcome
Timeframe: Pre-dose and 1 hour post-dose of Baseline, Weeks 4, 8, 12, 16, 24, 32, 36, 44, 52, 60, 68, 84, 96, 120 and 144Population: The pharmacokinetic (PK) population was defined as all participants in the ITT population who had at least one measurable BIIB054 concentration in serum or cerebrospinal fluid (CSF). Number analyzed is the number of participants analyzed at the specified time point.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=139 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=139 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=75 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Serum Concentration of BIIB054
Week 60 (1 Hour Post-dose)
|
657.94 micrograms per milliliter (ug/mL)
Standard Deviation 149.654
|
1905.43 micrograms per milliliter (ug/mL)
Standard Deviation 494.136
|
—
|
122.55 micrograms per milliliter (ug/mL)
Standard Deviation 29.374
|
|
Serum Concentration of BIIB054
Baseline (Pre-dose)
|
7.47 micrograms per milliliter (ug/mL)
Standard Deviation 51.281
|
0.01 micrograms per milliliter (ug/mL)
Standard Deviation 0.065
|
—
|
0.00 micrograms per milliliter (ug/mL)
Standard Deviation 0.000
|
|
Serum Concentration of BIIB054
Baseline (1 Hour Post-dose)
|
374.79 micrograms per milliliter (ug/mL)
Standard Deviation 86.004
|
1137.28 micrograms per milliliter (ug/mL)
Standard Deviation 335.336
|
—
|
75.02 micrograms per milliliter (ug/mL)
Standard Deviation 15.829
|
|
Serum Concentration of BIIB054
Week 4 (Pre-dose)
|
95.36 micrograms per milliliter (ug/mL)
Standard Deviation 27.882
|
306.20 micrograms per milliliter (ug/mL)
Standard Deviation 95.257
|
—
|
20.37 micrograms per milliliter (ug/mL)
Standard Deviation 5.004
|
|
Serum Concentration of BIIB054
Week 4 (1 Hour Post-dose)
|
468.56 micrograms per milliliter (ug/mL)
Standard Deviation 190.589
|
1354.19 micrograms per milliliter (ug/mL)
Standard Deviation 364.468
|
—
|
97.09 micrograms per milliliter (ug/mL)
Standard Deviation 19.711
|
|
Serum Concentration of BIIB054
Week 8 (Pre-dose)
|
169.79 micrograms per milliliter (ug/mL)
Standard Deviation 68.025
|
495.79 micrograms per milliliter (ug/mL)
Standard Deviation 153.357
|
—
|
29.73 micrograms per milliliter (ug/mL)
Standard Deviation 8.371
|
|
Serum Concentration of BIIB054
Week 8 (1 Hour Post-dose)
|
543.91 micrograms per milliliter (ug/mL)
Standard Deviation 143.212
|
1591.57 micrograms per milliliter (ug/mL)
Standard Deviation 465.798
|
—
|
103.69 micrograms per milliliter (ug/mL)
Standard Deviation 26.964
|
|
Serum Concentration of BIIB054
Week 12 (Pre-dose)
|
195.16 micrograms per milliliter (ug/mL)
Standard Deviation 51.020
|
580.43 micrograms per milliliter (ug/mL)
Standard Deviation 185.761
|
—
|
36.76 micrograms per milliliter (ug/mL)
Standard Deviation 11.830
|
|
Serum Concentration of BIIB054
Week 12 (1 Hour Post-dose)
|
569.41 micrograms per milliliter (ug/mL)
Standard Deviation 141.250
|
1632.29 micrograms per milliliter (ug/mL)
Standard Deviation 459.839
|
—
|
112.61 micrograms per milliliter (ug/mL)
Standard Deviation 27.378
|
|
Serum Concentration of BIIB054
Week 16 (Pre-dose)
|
201.33 micrograms per milliliter (ug/mL)
Standard Deviation 73.451
|
642.06 micrograms per milliliter (ug/mL)
Standard Deviation 194.288
|
—
|
40.82 micrograms per milliliter (ug/mL)
Standard Deviation 11.421
|
|
Serum Concentration of BIIB054
Week 16 (1 Hour Post-dose)
|
614.85 micrograms per milliliter (ug/mL)
Standard Deviation 186.892
|
1739.98 micrograms per milliliter (ug/mL)
Standard Deviation 506.346
|
—
|
117.08 micrograms per milliliter (ug/mL)
Standard Deviation 27.401
|
|
Serum Concentration of BIIB054
Week 24 (Pre-dose)
|
235.69 micrograms per milliliter (ug/mL)
Standard Deviation 84.454
|
724.60 micrograms per milliliter (ug/mL)
Standard Deviation 228.295
|
—
|
43.31 micrograms per milliliter (ug/mL)
Standard Deviation 12.906
|
|
Serum Concentration of BIIB054
Week 24 (1 Hour Post-dose)
|
664.26 micrograms per milliliter (ug/mL)
Standard Deviation 209.251
|
1867.92 micrograms per milliliter (ug/mL)
Standard Deviation 470.283
|
—
|
125.79 micrograms per milliliter (ug/mL)
Standard Deviation 36.695
|
|
Serum Concentration of BIIB054
Week 32 (Pre-dose)
|
260.35 micrograms per milliliter (ug/mL)
Standard Deviation 104.397
|
772.75 micrograms per milliliter (ug/mL)
Standard Deviation 299.703
|
—
|
42.69 micrograms per milliliter (ug/mL)
Standard Deviation 13.486
|
|
Serum Concentration of BIIB054
Week 32 (1 Hour Post-dose)
|
626.16 micrograms per milliliter (ug/mL)
Standard Deviation 164.497
|
1985.71 micrograms per milliliter (ug/mL)
Standard Deviation 497.545
|
—
|
139.00 micrograms per milliliter (ug/mL)
Standard Deviation 34.758
|
|
Serum Concentration of BIIB054
Week 36 (Pre-dose)
|
262.80 micrograms per milliliter (ug/mL)
Standard Deviation 85.052
|
819.83 micrograms per milliliter (ug/mL)
Standard Deviation 328.774
|
—
|
45.77 micrograms per milliliter (ug/mL)
Standard Deviation 11.867
|
|
Serum Concentration of BIIB054
Week 36 (1 Hour Post-dose)
|
665.60 micrograms per milliliter (ug/mL)
Standard Deviation 145.235
|
1916.84 micrograms per milliliter (ug/mL)
Standard Deviation 543.373
|
—
|
123.67 micrograms per milliliter (ug/mL)
Standard Deviation 29.536
|
|
Serum Concentration of BIIB054
Week 44 (Pre-dose)
|
280.40 micrograms per milliliter (ug/mL)
Standard Deviation 116.590
|
858.43 micrograms per milliliter (ug/mL)
Standard Deviation 349.573
|
—
|
58.17 micrograms per milliliter (ug/mL)
Standard Deviation 22.774
|
|
Serum Concentration of BIIB054
Week 44 (1 Hour Post-dose)
|
582.40 micrograms per milliliter (ug/mL)
Standard Deviation 194.431
|
2066.25 micrograms per milliliter (ug/mL)
Standard Deviation 579.555
|
—
|
143.33 micrograms per milliliter (ug/mL)
Standard Deviation 41.004
|
|
Serum Concentration of BIIB054
Week 52 (Pre-dose)
|
232.08 micrograms per milliliter (ug/mL)
Standard Deviation 87.529
|
787.35 micrograms per milliliter (ug/mL)
Standard Deviation 341.229
|
—
|
46.70 micrograms per milliliter (ug/mL)
Standard Deviation 19.343
|
|
Serum Concentration of BIIB054
Week 52 (1 Hour Post-dose)
|
645.36 micrograms per milliliter (ug/mL)
Standard Deviation 264.270
|
1920.78 micrograms per milliliter (ug/mL)
Standard Deviation 479.511
|
—
|
114.59 micrograms per milliliter (ug/mL)
Standard Deviation 25.913
|
|
Serum Concentration of BIIB054
Week 60 (Pre-dose)
|
254.52 micrograms per milliliter (ug/mL)
Standard Deviation 88.446
|
724.77 micrograms per milliliter (ug/mL)
Standard Deviation 314.854
|
—
|
43.41 micrograms per milliliter (ug/mL)
Standard Deviation 15.973
|
|
Serum Concentration of BIIB054
Week 68 (Pre-dose)
|
202.33 micrograms per milliliter (ug/mL)
Standard Deviation 34.210
|
1362.50 micrograms per milliliter (ug/mL)
Standard Deviation 533.866
|
—
|
706.25 micrograms per milliliter (ug/mL)
Standard Deviation 966.969
|
|
Serum Concentration of BIIB054
Week 68 (1 Hour Post-dose)
|
576.33 micrograms per milliliter (ug/mL)
Standard Deviation 85.290
|
2305.00 micrograms per milliliter (ug/mL)
Standard Deviation 1025.305
|
—
|
171.50 micrograms per milliliter (ug/mL)
Standard Deviation 44.548
|
|
Serum Concentration of BIIB054
Week 84 (Pre-dose)
|
255.54 micrograms per milliliter (ug/mL)
Standard Deviation 81.407
|
746.43 micrograms per milliliter (ug/mL)
Standard Deviation 249.770
|
—
|
47.00 micrograms per milliliter (ug/mL)
Standard Deviation 15.535
|
|
Serum Concentration of BIIB054
Week 84 (1 Hour Post-dose)
|
648.62 micrograms per milliliter (ug/mL)
Standard Deviation 120.163
|
1942.02 micrograms per milliliter (ug/mL)
Standard Deviation 501.095
|
—
|
134.91 micrograms per milliliter (ug/mL)
Standard Deviation 33.035
|
|
Serum Concentration of BIIB054
Week 96 (Pre-dose)
|
274.56 micrograms per milliliter (ug/mL)
Standard Deviation 71.718
|
654.70 micrograms per milliliter (ug/mL)
Standard Deviation 262.926
|
—
|
41.25 micrograms per milliliter (ug/mL)
Standard Deviation 15.345
|
|
Serum Concentration of BIIB054
Week 96 (1 Hour Post-dose)
|
682.30 micrograms per milliliter (ug/mL)
Standard Deviation 123.653
|
1822.50 micrograms per milliliter (ug/mL)
Standard Deviation 475.682
|
—
|
122.00 micrograms per milliliter (ug/mL)
Standard Deviation 29.527
|
|
Serum Concentration of BIIB054
Week 120 (Pre-dose)
|
279.00 micrograms per milliliter (ug/mL)
Standard Deviation 99.499
|
727.29 micrograms per milliliter (ug/mL)
Standard Deviation 116.793
|
—
|
34.98 micrograms per milliliter (ug/mL)
Standard Deviation 12.042
|
|
Serum Concentration of BIIB054
Week 120 (1 Hour Post-dose)
|
769.83 micrograms per milliliter (ug/mL)
Standard Deviation 279.182
|
1717.14 micrograms per milliliter (ug/mL)
Standard Deviation 320.037
|
—
|
119.67 micrograms per milliliter (ug/mL)
Standard Deviation 15.629
|
|
Serum Concentration of BIIB054
Week 144 (Pre-dose)
|
365.00 micrograms per milliliter (ug/mL)
Standard Deviation NA
NA: Standard Deviation was not determinable.
|
—
|
—
|
—
|
|
Serum Concentration of BIIB054
Week 144 (1 Hour Post-dose)
|
721.00 micrograms per milliliter (ug/mL)
Standard Deviation NA
NA: Standard Deviation was not determinable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). Number of participants analyzed were participants analyzed for this outcome measure.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=29 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=57 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=51 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=53 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in MDS-UPDRS Subpart I Score at Week 52
|
0.90 score on a scale
Standard Error 0.570
|
1.56 score on a scale
Standard Error 0.423
|
1.65 score on a scale
Standard Error 0.446
|
1.43 score on a scale
Standard Error 0.436
|
SECONDARY outcome
Timeframe: Baseline, Weeks 72 and 96Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from Placebo/BIIB054 250/1250/3500 mg for the analysis of this outcome measure. Number analyzed is the number of participants analyzed at the specified time point.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=55 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=102 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=100 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=100 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96
Change from Baseline at Week 72
|
0.61 score on a scale
Standard Error 0.538
|
1.73 score on a scale
Standard Error 0.402
|
1.63 score on a scale
Standard Error 0.405
|
1.65 score on a scale
Standard Error 0.395
|
|
Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96
Change from Baseline at Week 96
|
1.69 score on a scale
Standard Error 0.568
|
1.93 score on a scale
Standard Error 0.403
|
1.72 score on a scale
Standard Error 0.414
|
1.95 score on a scale
Standard Error 0.398
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). Number of participants analyzed were participants analyzed for this outcome measure.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=29 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=58 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=51 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=54 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in MDS-UPDRS Subpart II Score at Week 52
|
2.72 score on a scale
Standard Error 0.621
|
3.16 score on a scale
Standard Error 0.460
|
3.01 score on a scale
Standard Error 0.486
|
3.17 score on a scale
Standard Error 0.473
|
SECONDARY outcome
Timeframe: Baseline, Weeks 72 and 96Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from (Placebo/BIIB054 250/1250/3500 mg) for the analysis of this outcome measure. Number analyzed is the number of participants analyzed at the specified time point.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=55 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=102 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=100 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=100 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96
Change from Baseline at Week 72
|
1.62 score on a scale
Standard Error 0.672
|
2.36 score on a scale
Standard Error 0.497
|
1.68 score on a scale
Standard Error 0.503
|
1.83 score on a scale
Standard Error 0.491
|
|
Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96
Change from Baseline at Week 96
|
1.33 score on a scale
Standard Error 0.762
|
2.39 score on a scale
Standard Error 0.533
|
2.22 score on a scale
Standard Error 0.541
|
1.87 score on a scale
Standard Error 0.529
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). Number of participants analyzed were participants analyzed for this outcome measure.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=29 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=58 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=51 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=53 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in MDS-UPDRS Subpart III Score at Week 52
|
6.69 score on a scale
Standard Error 1.419
|
6.76 score on a scale
Standard Error 1.046
|
6.20 score on a scale
Standard Error 1.104
|
6.10 score on a scale
Standard Error 1.083
|
SECONDARY outcome
Timeframe: Baseline, Weeks 72 and 96Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from (Placebo/BIIB054 250/1250/3500 mg) for the analysis of this outcome measure. Number analyzed is the number of participants analyzed at the specified time point.
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=55 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=102 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=100 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=100 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96
Change from Baseline at Week 72
|
4.48 score on a scale
Standard Error 1.404
|
4.49 score on a scale
Standard Error 1.038
|
3.69 score on a scale
Standard Error 1.048
|
3.64 score on a scale
Standard Error 1.027
|
|
Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96
Change from Baseline at Week 96
|
5.14 score on a scale
Standard Error 1.679
|
4.39 score on a scale
Standard Error 1.180
|
5.17 score on a scale
Standard Error 1.201
|
4.49 score on a scale
Standard Error 1.174
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The pharmacodynamic population was defined as a subset of the ITT population with at least 1 post-baseline pharmacodynamic measurement.
SBR in the putamen as measured by SPECT imaging of the dopamine transporter (DaT) with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=52 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=97 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=84 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=91 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52
|
-0.098 striatal binding ratio
Standard Error 0.0199
|
-0.102 striatal binding ratio
Standard Error 0.0146
|
-0.125 striatal binding ratio
Standard Error 0.0155
|
-0.093 striatal binding ratio
Standard Error 0.0151
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The pharmacodynamic population was defined as a subset of the ITT population with at least 1 post-baseline pharmacodynamic measurement.
SBR in the striatum as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=52 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=97 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=84 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=91 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52
|
-0.090 striatal binding ratio
Standard Error 0.0191
|
-0.081 striatal binding ratio
Standard Error 0.0140
|
-0.108 striatal binding ratio
Standard Error 0.0148
|
-0.081 striatal binding ratio
Standard Error 0.0145
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The pharmacodynamic population was defined as a subset of the ITT population with at least 1 post-baseline pharmacodynamic measurement.
SBR in the caudate as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=52 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=97 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=84 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=91 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52
|
-0.075 striatal binding ratio
Standard Error 0.0219
|
-0.060 striatal binding ratio
Standard Error 0.0161
|
-0.089 striatal binding ratio
Standard Error 0.0171
|
-0.067 striatal binding ratio
Standard Error 0.0166
|
SECONDARY outcome
Timeframe: Up to Week 144Population: The analysis population for immunogenicity was defined as all participants in the safety population. As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from Placebo/BIIB054 250/1250/3500 mg for the analysis of this outcome measure.
Outcome measures
| Measure |
PC Period: Early Start BIIB054 250 mg
n=55 Participants
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: Early Start BIIB054 1250 mg
n=100 Participants
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
PC Period: Early Start BIIB054 3500 mg
n=99 Participants
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
|
BIIB054 250 mg
n=96 Participants
Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-BIIB054 Antibodies in the Serum
|
1.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
PC Period: Placebo
Serious events: 7 serious events
Other events: 58 other events
Deaths: 0 deaths
PC Period: BIIB054 250 mg (Early Start)
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
PC Period: BIIB054 1250 mg (Early Start)
Serious events: 4 serious events
Other events: 61 other events
Deaths: 0 deaths
PC Period: BIIB054 3500 mg (Early Start)
Serious events: 6 serious events
Other events: 63 other events
Deaths: 0 deaths
DBE Period: Placebo to BIIB054 250 mg (Delayed Start)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
DBE Period: BIIB054 250 mg (Early Start)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
DBE Period: BIIB054 1250 mg (Early Start)
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
DBE Period: BIIB054 3500 mg (Early Start)
Serious events: 7 serious events
Other events: 56 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PC Period: Placebo
n=100 participants at risk
Participants received BIIB054-matching placebo, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 250 mg (Early Start)
n=55 participants at risk
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 1250 mg (Early Start)
n=102 participants at risk
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 3500 mg (Early Start)
n=100 participants at risk
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
DBE Period: Placebo to BIIB054 250 mg (Delayed Start)
n=20 participants at risk
Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)
n=37 participants at risk
Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)
n=39 participants at risk
Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: BIIB054 250 mg (Early Start)
n=52 participants at risk
Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 250 mg in the PC period were included in this arm.
|
DBE Period: BIIB054 1250 mg (Early Start)
n=100 participants at risk
Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 1250 mg in the PC period were included in this arm.
|
DBE Period: BIIB054 3500 mg (Early Start)
n=94 participants at risk
Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 3500 mg in the PC period were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.8%
1/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.98%
1/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.8%
1/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Blood and lymphatic system disorders
Monoclonal B-cell lymphocytosis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
General disorders
Impaired healing
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Hepatobiliary disorders
Hepatitis toxic
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
COVID-19
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Viral infection
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.8%
1/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.98%
1/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.8%
1/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Sciatica
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Psychiatric disorders
Depression
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.98%
1/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.98%
1/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
Other adverse events
| Measure |
PC Period: Placebo
n=100 participants at risk
Participants received BIIB054-matching placebo, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 250 mg (Early Start)
n=55 participants at risk
Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 1250 mg (Early Start)
n=102 participants at risk
Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
PC Period: BIIB054 3500 mg (Early Start)
n=100 participants at risk
Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
|
DBE Period: Placebo to BIIB054 250 mg (Delayed Start)
n=20 participants at risk
Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)
n=37 participants at risk
Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)
n=39 participants at risk
Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
|
DBE Period: BIIB054 250 mg (Early Start)
n=52 participants at risk
Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 250 mg in the PC period were included in this arm.
|
DBE Period: BIIB054 1250 mg (Early Start)
n=100 participants at risk
Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 1250 mg in the PC period were included in this arm.
|
DBE Period: BIIB054 3500 mg (Early Start)
n=94 participants at risk
Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 3500 mg in the PC period were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
3/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.8%
1/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
5/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.7%
3/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.1%
2/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Vascular disorders
Hypertension
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.1%
2/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
5/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.1%
2/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Gastrointestinal disorders
Constipation
|
5.0%
5/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.5%
3/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.9%
5/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
6.0%
6/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.0%
4/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.4%
7/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
4/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
9.1%
5/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.9%
5/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
6.0%
6/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.0%
2/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.2%
3/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Gastrointestinal disorders
Nausea
|
6.0%
6/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.8%
1/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.9%
6/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
6.0%
6/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.3%
4/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.8%
2/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.0%
4/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.4%
7/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
General disorders
Fatigue
|
5.0%
5/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.6%
2/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.9%
3/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
9.0%
9/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.0%
4/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.3%
5/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
COVID-19
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.1%
2/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
6.0%
6/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.2%
3/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Influenza
|
3.0%
3/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.8%
1/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
6.9%
7/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Nasopharyngitis
|
12.0%
12/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
18.2%
10/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
9.8%
10/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
13.0%
13/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.0%
2/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.8%
2/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.0%
4/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.3%
5/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
3/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.6%
2/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.9%
6/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.0%
7/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.0%
2/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.8%
3/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.0%
2/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.1%
2/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
5/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
9.1%
5/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.9%
6/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
14.0%
14/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.0%
2/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.7%
3/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
19.2%
10/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
16.0%
16/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
17.0%
16/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.0%
2/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
7/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
9.1%
5/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
8.8%
9/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
11.0%
11/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.8%
4/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.7%
3/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.8%
3/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.0%
7/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.1%
2/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
8/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.5%
3/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.8%
8/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
13.0%
13/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.8%
4/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
15.4%
6/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
9.6%
5/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
5/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
8.5%
8/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.3%
4/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.9%
5/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.1%
2/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.8%
2/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.0%
2/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.1%
2/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Dizziness
|
3.0%
3/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.3%
4/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
8.8%
9/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
6.0%
6/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.1%
2/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.0%
4/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.3%
4/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Headache
|
18.0%
18/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.9%
6/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
18.6%
19/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
21.0%
21/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
15.0%
3/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
13.5%
5/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
12.8%
5/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.0%
7/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
12.8%
12/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Parkinson's disease
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
7.3%
4/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
8.8%
9/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
8.0%
8/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Psychiatric disorders
Anxiety
|
4.0%
4/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
8.8%
9/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
5/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.1%
2/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.3%
4/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.5%
3/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.9%
3/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.0%
3/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.0%
2/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
4.3%
4/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
10.8%
4/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.1%
2/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.8%
3/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.0%
2/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.1%
2/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.1%
2/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.0%
2/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.0%
2/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.1%
2/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
3.2%
3/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
General disorders
Asthenia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.4%
2/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.8%
3/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.1%
2/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.6%
1/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
2.7%
1/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Ear and labyrinth disorders
Paraesthesia ear
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Investigations
Blood glucose increased
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Investigations
Transaminases increased
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Investigations
Weight decreased
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Metabolism and nutrition disorders
Calcium deficiency
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.9%
1/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.1%
2/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.0%
1/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
1.1%
1/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/55 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/102 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
5.0%
1/20 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/37 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/39 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/52 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/100 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
0.00%
0/94 • Up to 3 years
Safety Population included all participants who received at least one dose of the study treatment (BIIB054 250 mg, 1250 mg, 3500 mg).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial 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