Trial Outcomes & Findings for A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS) (NCT NCT05123703)

Last Updated: 2026-07-15

Results Overview

The population-level summary is rate ratio of ARR. The ARR is calculated as the total number of protocol-defined relapses divided by the total patient-years. Protocol-defined relapse is the occurrence of new/worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by relatively stable or improving neurological state for ≥ 30 days. Symptoms must persist for \>24 hours \& should not be attributable to confounding clinical factors. The new/worsening neurological symptoms must be accompanied by objective neurological worsening consistent with an increase of at least half a step on the expanded disability status scale (EDSS) score, or 2 points on one of the appropriate functional system (FS) scores, or 1 point on two or more of the appropriate FS scores. The change must affect the selected FS (i.e., pyramidal, ambulation, cerebellar, brainstem, sensory, or visual). Adjusted values were reported. OM assessed non inferiority of ocrelizumab vs fingolimod.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

188 participants

Primary outcome timeframe

Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

Results posted on

2026-07-15

Participant Flow

A total of 187 participants with relapsing-remitting multiple sclerosis (RRMS) took part in the study at 79 investigative sites across 25 countries.

Participants were randomized in a 1:1 ratio to receive either ocrelizumab + fingolimod placebo or fingolimod + ocrelizumab placebo. The study is still ongoing.

Participant milestones

Participant milestones
Measure	Ocrelizumab Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Overall Study STARTED	93	94
Overall Study Safety-evaluable (SE) Population	93	92
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	93	94

Reasons for withdrawal

Reasons for withdrawal
Measure	Ocrelizumab Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Overall Study Lost to Follow-up	0	1
Overall Study Adverse Event	0	1
Overall Study Reason not Specified	1	1
Overall Study Physician Decision	0	2
Overall Study Withdrawal by Subject	3	8
Overall Study Ongoing in Study	89	81

Baseline Characteristics

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocrelizumab n=93 Participants Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod n=94 Participants Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Total n=187 Participants Total of all reporting groups
Age, Continuous	15.0 years STANDARD_DEVIATION 1.5 • n=20 Participants	15.0 years STANDARD_DEVIATION 1.5 • n=20 Participants	15.0 years STANDARD_DEVIATION 1.5 • n=40 Participants
Sex: Female, Male Female	67 Participants n=20 Participants	62 Participants n=20 Participants	129 Participants n=40 Participants
Sex: Female, Male Male	26 Participants n=20 Participants	32 Participants n=20 Participants	58 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=20 Participants	18 Participants n=20 Participants	44 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=20 Participants	55 Participants n=20 Participants	105 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=20 Participants	21 Participants n=20 Participants	38 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=20 Participants	3 Participants n=20 Participants	7 Participants n=40 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	3 Participants n=20 Participants	6 Participants n=20 Participants	9 Participants n=40 Participants
Race (NIH/OMB) White	63 Participants n=20 Participants	60 Participants n=20 Participants	123 Participants n=40 Participants
Race (NIH/OMB) More than one race	6 Participants n=20 Participants	4 Participants n=20 Participants	10 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=20 Participants	20 Participants n=20 Participants	36 Participants n=40 Participants

PRIMARY outcome

Timeframe: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

Population: FAS included all randomized participants, with participants grouped according to their assigned treatment.

Outcome measures

Outcome measures
Measure	Ocrelizumab n=93 Participants Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod n=94 Participants Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Protocol-defined Annualized Relapse Rate (ARR)	0.070 relapses per patient-year Interval 0.034 to 0.144	0.135 relapses per patient-year Interval 0.075 to 0.243

SECONDARY outcome

Timeframe: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

Population: FAS included all randomized participants, with participants grouped according to their assigned treatment.

Outcome measures

Outcome measures
Measure	Ocrelizumab n=93 Participants Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod n=94 Participants Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Protocol-defined ARR	0.070 relapses per patient-year Interval 0.034 to 0.144	0.135 relapses per patient-year Interval 0.075 to 0.243

SECONDARY outcome

Timeframe: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

Population: FAS included all randomized participants, with participants grouped according to their assigned treatment.

Number of new or enlarging T2 lesions for each participant was calculated as the sum of the individual number of new or enlarging T2 lesions as detected by brain MRI.

Outcome measures

Outcome measures
Measure	Ocrelizumab n=93 Participants Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod n=94 Participants Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Number of New or Enlarging T2-hyperintense Lesions (T2 Lesions), as Detected by Brain Magnetic Resonance Imaging (MRI)	495 lesions	908 lesions

SECONDARY outcome

Timeframe: At Week 12

Population: FAS included all randomized participants, with participants grouped according to their assigned treatment. Overall number analyzed is the number of participants with data available for analysis.

Brain MRI with and without a Gd-contrast agent were performed to assess the number of Gd lesions.

Outcome measures

Outcome measures
Measure	Ocrelizumab n=93 Participants Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod n=88 Participants Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Number of T1 Gd Lesions at Week 12	5 lesions	33 lesions

SECONDARY outcome

Timeframe: Up to approximately 7 years

An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle (1 Cycle=24 weeks)

Population: Pharmacokinetic (PK)-evaluable population included all participants who had measurable concentrations of ocrelizumab.

Outcome measures

Outcome measures
Measure	Ocrelizumab n=93 Participants Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Maximum Serum Concentration (Cmax) of Ocrelizumab	142 micrograms per milliliter (µg/ml) Geometric Coefficient of Variation 0.173	—

SECONDARY outcome

Timeframe: Cycle 1 (1 Cycle=24 weeks)

Population: PK-evaluable population included all participants who had measurable concentrations of ocrelizumab.

Outcome measures

Outcome measures
Measure	Ocrelizumab n=93 Participants Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC Tau) of Ocrelizumab	3020 µg/mL.day Geometric Coefficient of Variation 0.266	—

SECONDARY outcome

Timeframe: Up to approximately 7 years

Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to atezolizumab was determined by summing the ADA-positive participants across all timepoints.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 7 years

CD19+ B-cell count in blood will be assessed using flow cytometry.

Outcome measures

Outcome data not reported

Adverse Events

Ocrelizumab

Serious events: 6 serious events

Other events: 76 other events

Deaths: 0 deaths

Fingolimod

Serious events: 8 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ocrelizumab n=93 participants at risk Participants received ocrelizumab, 600 milligrams (mg), administered as two 300 mg intravenous (IV) infusions on Days 1 and 15 of Cycle 1, and thereafter as a single dose of 600 mg, as IV infusion, every 24 weeks (Q24W), along with fingolimod placebo, PO, QD until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).	Fingolimod n=92 participants at risk Participants received fingolimod, 0.5 mg, PO, QD, along with ocrelizumab placebo, administered as two IV infusions on Days 1 and 15 of Cycle 1, and thereafter as a single IV infusion, Q24W until after the last participant randomized had completed 24 weeks since first study treatment administration (1 Cycle=24 weeks).
Blood and lymphatic system disorders Neutropenia	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 2 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Cardiac disorders Sinus bradycardia	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
General disorders General physical health deterioration	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Infections and infestations Conjunctivitis	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Infections and infestations Dengue fever	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Infections and infestations Influenza	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Infections and infestations Peritonitis	1.1% 1/93 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	0.00% 0/92 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Infections and infestations Pneumonia	2.2% 2/93 • Number of events 3 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Injury, poisoning and procedural complications Infusion related reaction	1.1% 1/93 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	0.00% 0/92 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 2 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Investigations Electrocardiogram QT prolonged	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Investigations Transaminases increased	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Nervous system disorders Headache	1.1% 1/93 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	0.00% 0/92 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Psychiatric disorders Anxiety disorder	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Psychiatric disorders Conversion disorder	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Psychiatric disorders Mental disorder	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Psychiatric disorders Psychotic disorder	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 2 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Psychiatric disorders Suicidal ideation	1.1% 1/93 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	0.00% 0/92 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.
Renal and urinary disorders Nephrolithiasis	0.00% 0/93 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.	1.1% 1/92 • Number of events 1 • Up to approximately 160 weeks SE population included all randomized participants who received at least one dose (partial or complete) of study drug (ocrelizumab or fingolimod), with participants grouped according to their actual treatment received. Study is still ongoing \& final AE data will be reported 1 year after study completion.