Trial Outcomes & Findings for Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis (NCT NCT01051349)

NCT ID: NCT01051349

Last Updated: 2018-11-09

Results Overview

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 410 participants
• Primary outcome timeframe: Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
• Results posted on: 2018-11-09

Participant Flow

Out of 410 enrolled participants, 60 participants who received at least 6 consecutive monthly doses of DAC HYP in this study and had provided written informed consent were enrolled in to the autoinjector substudy and 91 participants who received seasonal trivalent influenza vaccine were enrolled in vaccine substudy (exploratory analyses).

Participant milestones

Measure	BIIB019 Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
Overall Study STARTED	410
Overall Study COMPLETED	237
Overall Study NOT COMPLETED	173

Reasons for withdrawal

Measure	BIIB019 Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
Overall Study Adverse Event	88
Overall Study Consent Withdrawn	54
Overall Study Investigator Decision	6
Overall Study Lost to Follow-up	6
Overall Study Subject non-compliance	7
Overall Study Reason not Specified	12

Baseline Characteristics

Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis

Baseline characteristics by cohort

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
Age, Continuous	38.4 years STANDARD_DEVIATION 8.74 • n=5 Participants
Sex: Female, Male Female	254 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)

Population: Safety population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs Number of participants with an AEs	358 Participants	—
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs Number of participants with SAEs	148 Participants	—
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs Participants discontinuing treatment due to AE	91 Participants	—
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs Participants withdrawing from study due to AE	90 Participants	—

PRIMARY outcome

Timeframe: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

Population: Pharmacokinetic analysis population included all participants in the Autoinjector Substudy with a sufficient number of samples available for analysis by randomized treatment group.

Outcome measures

Measure	BIIB019 n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab	610.5 hr*mg/mL Standard Deviation 253.89	666.8 hr*mg/mL Standard Deviation 253.19

SECONDARY outcome

Timeframe: From Baseline through 288 weeks

Population: Intent-to-treat (ITT) population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.

New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 144 New/newly enlarging T2 lesions=3	2 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 144 New/newly enlarging T2 lesions=4	1 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 144 New/newly enlarging T2 lesions=5-6	4 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 144 New/newly enlarging T2 lesions=7-10	1 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 144 New/newly enlarging T2 lesions>=11	6 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 192 New/newly enlarging T2 lesions=0	144 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 192 New/newly enlarging T2 lesions=1	30 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 192 New/newly enlarging T2 lesions=2	24 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 192 New/newly enlarging T2 lesions=3	13 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 192 New/newly enlarging T2 lesions=4	9 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 192 Ne/newly enlarging T2 lesions=5-6	11 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 192 New/newly enlarging T2lesions=7-10	11 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 192 New/newly enlarging T2 lesions>=11	20 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 240 New/newly enlarging T2 lesions=0	60 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 240 New/newly enlarging T2 lesions=1	10 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 240 New/newly enlarging T2 lesions=2	14 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 240 New/newly enlarging T2 lesions=3	9 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 240 New/newly enlarging T2 lesions=4	7 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 240 New/newly enlarging T2 lesions=5-6	7 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 240 New/newly enlarging T2lesions=7-10	3 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 240 New/newly enlarging T2 lesions>=11	11 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 288 New/newly enlarging T2 lesions=0	14 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 96 New/newly enlarging T2 lesions=3	17 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 96 New/newly enlarging T2 lesions=4	11 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 96 New/newly enlarging T2 lesions=5-6	6 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 96 New/newly enlarging T2 lesions=7-10	10 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 96 New/newly enlarging T2 lesions>=11	18 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 144 New/newly enlarging T2 lesions=0	33 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 144 New/newly enlarging T2 lesions=1	5 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 144 New/newly enlarging T2 lesions=2	1 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 48 New or newly enlarging T2 lesions=0	255 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 48 New or newly enlarging T2 lesions=1	39 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 48 New or newly enlarging T2 lesions=2	27 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 48 New or newly enlarging T2 lesions=3	12 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 48 New or newly enlarging T2 lesions=4	5 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 48 New/newly enlarging T2 lesions=5-6	6 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 48 New/newly enlarging T2 lesions=7-10	8 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 48 New/newly enlarging T2 lesions>=11	11 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 96 New/newly enlarging T2 lesions=0	213 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 96 New/newly enlarging T2 lesions=1	41 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 96 New/newly enlarging T2 lesions=2	17 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 288 New/newly enlarging T2 lesions=1	1 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 288 New/newly enlarging T2 lesions=2	4 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 288 New/ newly enlarging T2 lesions=3	1 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 288 New/newly enlarging T2 lesions=4	0 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 288 New/newly enlarging T2 lesions=5-6	1 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 288 New/newly enlarging T2 lesions=7-10	3 Participants	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Week 288 New/newly enlarging T2 lesions>=11	3 Participants	—

SECONDARY outcome

Timeframe: From Baseline through 288 weeks

Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.

New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Change from Baseline at Week 48	-340.8 mm^3 Standard Deviation 1237.64	—
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Change from Baseline at Week 96	-237.7 mm^3 Standard Deviation 1382.86	—
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Change from Baseline at Week 144	38.2 mm^3 Standard Deviation 1825.06	—
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Change from Baseline at Week 192	-251.2 mm^3 Standard Deviation 2326.41	—
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Change from Baseline at Week 240	-269.7 mm^3 Standard Deviation 1188.82	—
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline Change from Baseline at Week 288	31.9 mm^3 Standard Deviation 1008.87	—

SECONDARY outcome

Timeframe: From Baseline through 288 weeks

Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.

New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 48 new Gd-enhancing lesions=1	22 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 48 new Gd-enhancing lesions=2	3 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 48 new Gd-enhancing lesions=3	6 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 48 new Gd-enhancing lesions=>4	11 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 96 new Gd-enhancing lesions=1	14 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 96 new Gd-enhancing lesions=2	7 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 96 new Gd-enhancing lesions=3	4 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 96 new Gd-enhancing lesions=>4	5 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 144 new Gd-enhancing lesions=1	1 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 144 new Gd-enhancing lesions=2	0 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 144 new Gd-enhancing lesions=3	1 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 144 new Gd-enhancing lesions=>4	2 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 192 new Gd-enhancing lesions=1	13 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 192 new Gd-enhancing lesions=2	5 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 192 new Gd-enhancing lesions=3	1 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 192 new Gd-enhancing lesions=>4	0 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 240 new Gd-enhancing lesions=1	5 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 240 new Gd-enhancing lesions=2	0 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 240 new Gd-enhancing lesions=3	0 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 240 new Gd-enhancing lesions=>4	0 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 288 new Gd-enhancing lesions=1	2 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 288 new Gd-enhancing lesions=2	0 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 288 new Gd-enhancing lesions=3	0 Participants	—
Number of Participants With Total Number of New Gadolinium-enhancing Lesions Week 288 new Gd-enhancing lesions=>4	0 Participants	—

SECONDARY outcome

Timeframe: From Baseline through 288 weeks

Population: T1 hypointense lesions changes reflect tissue destruction. Volume of T1 hypointense lesions is deemed a more valuable assessment. Hence number of T1 hypointense lesions were not assessed and reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline through 288 weeks

Population: Gd enhancing lesion volume reflects acute inflammatory activity. The number of Gd lesions is a more valuable outcome measure. Hence the volume of Gd enhancing lesions was not assessed and reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline through 288 weeks

Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.

Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Annual Change in Volume of T1 Hypointense Lesions Change from Baseline at Week 48	-183.5 mm^3 Standard Deviation 370.66	—
Annual Change in Volume of T1 Hypointense Lesions Change from Baseline at Week 96	-160.6 mm^3 Standard Deviation 443.78	—
Annual Change in Volume of T1 Hypointense Lesions Change from Baseline at Week 144	-142.4 mm^3 Standard Deviation 432.57	—
Annual Change in Volume of T1 Hypointense Lesions Change from Baseline at Week 192	-115.2 mm^3 Standard Deviation 826.84	—
Annual Change in Volume of T1 Hypointense Lesions Change from Baseline at Week 240	-140.8 mm^3 Standard Deviation 514.38	—
Annual Change in Volume of T1 Hypointense Lesions Change from Baseline at Week 288	-148.4 mm^3 Standard Deviation 500.07	—

SECONDARY outcome

Timeframe: From Baseline through 288 weeks

Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.

To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Percent Change in Total Brain Volume Change from Week 96 to Week 144	-0.2 percent change Standard Deviation 1.00	—
Percent Change in Total Brain Volume Change from Week 144 to Week 192	-0.5 percent change Standard Deviation 0.59	—
Percent Change in Total Brain Volume Change from Week 192 to Week 240	-0.2 percent change Standard Deviation 0.83	—
Percent Change in Total Brain Volume Change from Week 240 to Week 288	0.1 percent change Standard Deviation 0.73	—
Percent Change in Total Brain Volume Change from Week 0 to Week 48	-0.4 percent change Standard Deviation 1.00	—
Percent Change in Total Brain Volume Change from Week 48 to Week 96	-0.4 percent change Standard Deviation 0.78	—

SECONDARY outcome

Timeframe: Up to Week 288

Population: Safety population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here number of participants analyzed is the participants who were evaluated for this outcome measure.

Outcome measures

Measure	BIIB019 n=407 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Number of Participants With Antibodies to DAC HYP	43 Participants	—

SECONDARY outcome

Timeframe: Week 288

Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.

Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365. Adjusted ARR was reported.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Annualized Relapse Rate (ARR)	0.124 relapses per person-year Interval 0.099 to 0.156	—

SECONDARY outcome

Timeframe: Week 48 up to Week 288

Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.

Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Number of Participants With Sustained Disability Progression for 12 Weeks Weeks 0 - 48	22 Participants	—
Number of Participants With Sustained Disability Progression for 12 Weeks Weeks 49 - 96	17 Participants	—
Number of Participants With Sustained Disability Progression for 12 Weeks Weeks 97 - 144	13 Participants	—
Number of Participants With Sustained Disability Progression for 12 Weeks Weeks 145 -192	7 Participants	—
Number of Participants With Sustained Disability Progression for 12 Weeks Week 193 - 288	2 Participants	—

SECONDARY outcome

Timeframe: Week 48 up to Week 288

Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.

Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.

Outcome measures

Measure	BIIB019 n=410 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Number of Participants With Sustained Disability Progression for 24 Weeks Weeks 0 - 48	19 Participants	—
Number of Participants With Sustained Disability Progression for 24 Weeks Weeks 49 - 96	18 Participants	—
Number of Participants With Sustained Disability Progression for 24 Weeks Weeks 97 - 144	11 Participants	—
Number of Participants With Sustained Disability Progression for 24 Weeks Weeks 145 -192	7 Participants	—
Number of Participants With Sustained Disability Progression for 24 Weeks Week 193 - 288	3 Participants	—

SECONDARY outcome

Timeframe: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

Population: Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.

Outcome measures

Measure	BIIB019 n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab	31.8 mg/mL Standard Deviation 13.11	33.6 mg/mL Standard Deviation 14.79

SECONDARY outcome

Timeframe: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

Population: Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.

Outcome measures

Measure	BIIB019 n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4	5.0 hour Interval 1.0 to 14.0	6.0 hour Interval 1.0 to 14.0

SECONDARY outcome

Timeframe: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

Population: Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.

Outcome measures

Measure	BIIB019 n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4	13.8 mg/mL Standard Deviation 7.13	15.7 mg/mL Standard Deviation 7.31

SECONDARY outcome

Timeframe: First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose

Population: The participants who were enrolled in auto-injector sub study were evaluated in this outcome measure. Here 'n' indicates number of participants who were evaluable at specific time points.

The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end ("0 [no pain]" on the left and "100 [very painful]" on the right). The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.

Outcome measures

Measure	BIIB019 n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Participant-Reported Pain Visual Analog Scale (VAS) Score First injection, 8 hours post-dose	0.1 score on a scale Standard Deviation 0.25	0.2 score on a scale Standard Deviation 0.50
Participant-Reported Pain Visual Analog Scale (VAS) Score First injection, 0 hour post-dose	12.7 score on a scale Standard Deviation 17.45	14.5 score on a scale Standard Deviation 19.47
Participant-Reported Pain Visual Analog Scale (VAS) Score First injection, 30 minutes post-dose	0.1 score on a scale Standard Deviation 0.31	0.4 score on a scale Standard Deviation 1.01
Participant-Reported Pain Visual Analog Scale (VAS) Score First injection, 60 minutes post-dose	0.1 score on a scale Standard Deviation 0.25	0.3 score on a scale Standard Deviation 0.60
Participant-Reported Pain Visual Analog Scale (VAS) Score Fourth injection, 0 hour post-dose	14.5 score on a scale Standard Deviation 21.7	15.6 score on a scale Standard Deviation 24.70
Participant-Reported Pain Visual Analog Scale (VAS) Score Fourth injection, 30 minutes post-dose	0.9 score on a scale Standard Deviation 3.51	1.3 score on a scale Standard Deviation 3.42
Participant-Reported Pain Visual Analog Scale (VAS) Score Fourth injection, 60 minutes post-dose	0.0 score on a scale Standard Deviation 0.18	0.1 score on a scale Standard Deviation 0.31
Participant-Reported Pain Visual Analog Scale (VAS) Score Fourth injection, 8 hours post-dose	0.1 score on a scale Standard Deviation 0.40	0.1 score on a scale Standard Deviation 0.31

SECONDARY outcome

Timeframe: First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose

Population: The participants who were enrolled in auto-injector sub study were evaluated in this outcome measure. Here 'n' indicates number of participants who were evaluable at specific time points.

Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported.

Here, Injection=Inj, post-dose=PD

Outcome measures

Measure	BIIB019 n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.	BIIB019 (Autoinjector [AI]) n=30 Participants Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
Summary of Injection Site Assessment Performed by Clinician Erythema: Ist Inj 30 min PD: None	29 Participants	29 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema:Ist Inj 30 min PD: Mild	1 Participants	1 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: Ist Inj 8 h PD: None	30 Participants	29 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema:Ist Inj 8 h PD: MIld	0 Participants	1 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: Ist Inj 24 h PD: None	28 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: Ist Inj 72 h PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: Ist Inj 120 h PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: Ist Inj 7 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: Ist Inj 10 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: Ist Inj 14 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 30 min PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 30 min PD: Mild	0 Participants	1 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 8 h PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 24 h PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 72 h PD: None	29 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 120 h PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 7 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 10 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Erythema: 4th Inj 14 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 1st Inj, 30 min PD: None	30 Participants	30 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 1st Inj, 8 h PD: None	30 Participants	30 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 1st Inj, 24 h PD: None	28 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 1st Inj, 72 h PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 1st Inj, 120 h PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 1st Inj, 7 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 1st Inj, 10 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 1st Inj, 14 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 30 min PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 8 h PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 24 h PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 72 h PD: None	28 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 72 h PD: Hyper-	1 Participants	0 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 120 h PD: None	29 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 120 h PD: Hyper-	1 Participants	0 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 7 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 10 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Pigmentation: 4th Inj, 14 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 1st Inj, 30 min PD: None	30 Participants	30 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 1st Inj, 8 h PD: None	30 Participants	30 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 1st Inj, 24 h PD: None	28 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 1st Inj, 72 h PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 1st Inj, 120 h PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 1st Inj, 7 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 1st Inj, 10 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 1st Inj, 14 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 4th Inj, 30 min PD: None (n=30, 28)	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 4th Inj, 8 h PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 4th Inj, 24 h PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 4th Inj, 72 h PD: None	29 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 4th Inj, 120 h PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 4th Inj, 7 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 4th Inj, 10 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Induration: 4th Inj, 14 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 30 min PD: None	30 Participants	29 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 30 min PD: Mild	0 Participants	1 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 8 h PD: None	30 Participants	30 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 24 h PD: None	28 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 72 h PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 120 h PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 7 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 10 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 1st Inj, 14 days PD: None	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 30 min PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 30 min PD: Mild	0 Participants	1 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 8 h PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 8 h PD: Mild	0 Participants	1 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 24 h PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 72 h PD: None	29 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 120 h PD: None	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 7 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 10 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Tenderness: 4th Inj, 14 days PD: None	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 1st Inj, 30 min PD: Normal	30 Participants	30 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 1st Inj, 8 h PD: Normal	30 Participants	30 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 1st Inj, 24 h PD: Normal	28 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 1st Inj, 72 h PD: Normal	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 1st Inj, 120 h PD: Normal	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 1st Inj, 7 days PD: Normal	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 1st Inj,10 days PD: Normal	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 1st Inj,14 days PD: Normal	26 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 4th Inj, 30 min PD: Normal	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 4th Inj, 8 h PD: Normal	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 4th Inj, 24 h PD: Normal	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 4th Inj, 72 h PD: Normal	29 Participants	26 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 4th Inj, 120 h PD: Normal	30 Participants	27 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 4th Inj, 7 days PD: Normal	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 4th Inj,10 days PD: Normal	30 Participants	28 Participants
Summary of Injection Site Assessment Performed by Clinician Temperature: 4th Inj,14 days PD: Normal	30 Participants	28 Participants

Adverse Events

BIIB019

Serious events: 148 serious events

Other events: 296 other events

Deaths: 0 deaths

Serious adverse events

Measure	BIIB019 n=410 participants at risk Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
Blood and lymphatic system disorders Febrile neutropenia	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Haemolytic anaemia	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Histiocytosis haematophagic	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Iron deficiency anaemia	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Lymphadenitis	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Lymphadenopathy	1.5% 6/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Lymphoid tissue hyperplasia	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Pancytopenia	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Cardiac disorders Myocardial infarction	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Congenital, familial and genetic disorders Dermoid cyst	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Ear and labyrinth disorders Vertigo	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Endocrine disorders Goitre	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Eye disorders Choroiditis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Abdominal hernia	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Colitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Colitis ulcerative	0.73% 3/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Crohn's disease	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Diarrhoea	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Gastritis	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Ileus	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Ileus paralytic	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Lip oedema	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Obstruction gastric	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
General disorders Impaired healing	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Hepatobiliary disorders Autoimmune hepatitis	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Hepatobiliary disorders Cholecystitis acute	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Hepatobiliary disorders Cholelithiasis	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Hepatobiliary disorders Hepatitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Hepatobiliary disorders Jaundice hepatocellular	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Hepatobiliary disorders Liver disorder	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Immune system disorders Anaphylactic reaction	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Immune system disorders Drug hypersensitivity	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Acute sinusitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Appendicitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Bronchitis	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Clostridium difficile colitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Diverticulitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Erysipelas	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Furuncle	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Gastrointestinal infection	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Hepatitis c	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Herpes zoster	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Hiv infection	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Infectious mononucleosis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Peritonsillar abscess	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Pneumonia	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Pyelonephritis acute	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Tonsillitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Upper respiratory tract infection	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Urinary tract infection	1.2% 5/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Wound infection	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Concussion	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Foot fracture	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Lower limb fracture	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Pubis fracture	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Road traffic accident	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Spinal column injury	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Upper limb fracture	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Wound	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Investigations Alanine aminotransferase increased	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Investigations Aspartate aminotransferase increased	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Investigations Gamma-glutamyltransferase increased	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Investigations Hepatic enzyme increased	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Investigations Liver function test abnormal	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Musculoskeletal and connective tissue disorders Back pain	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.73% 3/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour pulmonary	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prolactinoma	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Grand mal convulsion	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Headache	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Ischaemic stroke	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Multiple sclerosis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Multiple sclerosis relapse	15.1% 62/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Neurological decompensation	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Vascular encephalopathy	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Psychiatric disorders Depression	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Psychiatric disorders Suicide attempt	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Renal and urinary disorders Glomerulonephritis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Renal and urinary disorders Haematuria	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Renal and urinary disorders Nephroptosis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Renal and urinary disorders Renal colic	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Reproductive system and breast disorders Adenomyosis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Reproductive system and breast disorders Ovarian cyst	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Reproductive system and breast disorders Uterine inflammation	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Angioedema	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Dermatitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Drug eruption	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Eczema	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Erythema nodosum	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Photodermatosis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Psoriasis	0.49% 2/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Stevens-johnson syndrome	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.73% 3/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Urticaria	0.73% 3/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Surgical and medical procedures Drug detoxification	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Surgical and medical procedures Eyelid operation	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Surgical and medical procedures Mammoplasty	0.24% 1/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.

Other adverse events

Measure	BIIB019 n=410 participants at risk Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
Blood and lymphatic system disorders Lymphadenopathy	5.6% 23/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Gastrointestinal disorders Diarrhoea	6.1% 25/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Bronchitis	6.8% 28/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Nasopharyngitis	16.6% 68/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Pharyngitis	10.2% 42/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Respiratory tract infection viral	8.5% 35/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Upper respiratory tract infection	14.6% 60/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Urinary tract infection	10.2% 42/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Infections and infestations Viral infection	5.6% 23/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Injury, poisoning and procedural complications Fall	5.1% 21/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Investigations Alanine aminotransferase increased	14.9% 61/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Investigations Aspartate aminotransferase increased	12.0% 49/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 21/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Musculoskeletal and connective tissue disorders Back pain	9.5% 39/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Headache	10.7% 44/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Nervous system disorders Multiple sclerosis relapse	26.8% 110/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Dermatitis allergic	7.8% 32/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Rash	7.6% 31/410 • Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.

Additional Information

Biogen Study Medical Director

Biogen

Phone: 866-633-4636

Email: clinicaltrials@biogen.com

Results disclosure agreements

• Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
• Publication restrictions are in place

Restriction type: OTHER