Trial Outcomes & Findings for A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (NCT NCT04075266)

NCT ID: NCT04075266

Last Updated: 2025-12-23

Results Overview

The population PK model was used to simulate concentration-time course and predict individual area under the concentration versus time curve. The data for the PK parameter: area under the concentration versus time curve was collected and analyzed as per body weight range (\<40kg to ≥40 kg).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113
• Results posted on: 2025-12-23

Participant Flow

Participants took part in the study across 12 investigative sites in 3 countries (the United States, Poland, and Italy). This study is still ongoing.

A total of 23 participants with relapsing-remitting multiple sclerosis (RRMS) received ocrelizumab per a weight-based dosing regimen.

Participant milestones

Measure	Ocrelizumab 300 mg Participants who weighed between 25 kilograms (kg) to 40 kg were administered first dose of 300 milligrams (mg) ocrelizumab as two intravenous (IV) infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week optional ocrelizumab extension (OOE) period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.	Ocrelizumab 600 mg Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.
Dose Exploration Period: 24 Week STARTED	6	17
Dose Exploration Period: 24 Week COMPLETED	6	17
Dose Exploration Period: 24 Week NOT COMPLETED	0	0
OOE Period: 264 Week STARTED	6	17
OOE Period: 264 Week COMPLETED	0	0
OOE Period: 264 Week NOT COMPLETED	6	17

Reasons for withdrawal

Measure	Ocrelizumab 300 mg Participants who weighed between 25 kilograms (kg) to 40 kg were administered first dose of 300 milligrams (mg) ocrelizumab as two intravenous (IV) infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week optional ocrelizumab extension (OOE) period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.	Ocrelizumab 600 mg Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.
OOE Period: 264 Week Ongoing in Study	5	17
OOE Period: 264 Week Withdrawal by Subject	1	0

Baseline Characteristics

Number analyzed is the number of participants with data available for analysis.

Baseline characteristics by cohort

Measure	Ocrelizumab 300 mg n=6 Participants Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.	Ocrelizumab 600 mg n=17 Participants Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.	Total n=23 Participants Total of all reporting groups
Age, Continuous	11.2 years STANDARD_DEVIATION 0.8 • n=6 Participants	15.3 years STANDARD_DEVIATION 1.8 • n=17 Participants	14.2 years STANDARD_DEVIATION 2.4 • n=23 Participants
Sex: Female, Male Female	5 Participants n=6 Participants	10 Participants n=17 Participants	15 Participants n=23 Participants
Sex: Female, Male Male	1 Participants n=6 Participants	7 Participants n=17 Participants	8 Participants n=23 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6 Participants	3 Participants n=17 Participants	3 Participants n=23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=6 Participants	14 Participants n=17 Participants	20 Participants n=23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=23 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Asian	1 Participants n=6 Participants	0 Participants n=17 Participants	1 Participants n=23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	1 Participants n=17 Participants	1 Participants n=23 Participants
Race (NIH/OMB) White	5 Participants n=6 Participants	16 Participants n=17 Participants	21 Participants n=23 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=23 Participants
Cluster of Differentiation (CD) 19+B cells	287 cells/microliters (cells/µL) n=5 Participants • Number analyzed is the number of participants with data available for analysis.	234 cells/microliters (cells/µL) n=17 Participants • Number analyzed is the number of participants with data available for analysis.	246 cells/microliters (cells/µL) n=22 Participants • Number analyzed is the number of participants with data available for analysis.

PRIMARY outcome

Timeframe: Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113

Population: Pharmacokinetic (PK) evaluable population included all participants who were enrolled in the study.

The population PK model was used to simulate concentration-time course and predict individual area under the concentration versus time curve. The data for the PK parameter: area under the concentration versus time curve was collected and analyzed as per body weight range (<40kg to ≥40 kg).

Outcome measures

Measure	Body Weight < 40 kg n=6 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=17 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Area Under the Concentration Versus Time Curve of Ocrelizumab	2187 microgram/milliters*day (µg/mL*day) Interval 1565.0 to 3090.0	3197 microgram/milliters*day (µg/mL*day) Interval 1781.0 to 4339.0

PRIMARY outcome

Timeframe: Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113

Population: PK evaluable population included all participants who were enrolled in the study.

The population PK model was used to simulate concentration-time course and predict individual Cmax. The data for the PK parameter: Cmax was collected and analyzed as per body weight range (<40kg to ≥40 kg).

Outcome measures

Measure	Body Weight < 40 kg n=6 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=17 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Maximum Concentration (Cmax) of Ocrelizumab	106 microgram/milliters (µg/mL) Interval 81.0 to 142.0	158 microgram/milliters (µg/mL) Interval 113.0 to 209.0

PRIMARY outcome

Timeframe: At Week 24

Population: Safety evaluable population included all participants who received at least one dose of study drug.

Outcome measures

Measure	Body Weight < 40 kg n=6 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=17 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Levels of CD 19+ B-cell Count in Blood	91.00 cells/µL Interval 24.0 to 404.0	9.00 cells/µL Interval 1.0 to 151.0

SECONDARY outcome

Timeframe: Up to 7 years

An AE is untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 24

Population: Safety evaluable population included all participants who received at least one dose of study drug.

Outcome measures

Measure	Body Weight < 40 kg n=6 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=17 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Level of Circulating T Cells and Natural Killer (NK) Cells CD3+ Total T cell	1637.67 cells/microliter (µL) Standard Deviation 578.50	1506.0 cells/microliter (µL) Standard Deviation 468.68
Dose Exploration Period: Level of Circulating T Cells and Natural Killer (NK) Cells CD4+ Helper T cell	1044.0 cells/microliter (µL) Standard Deviation 329.0	889.18 cells/microliter (µL) Standard Deviation 252.58
Dose Exploration Period: Level of Circulating T Cells and Natural Killer (NK) Cells CD8+ Cytotoxic T cell	441.83 cells/microliter (µL) Standard Deviation 180.32	532.65 cells/microliter (µL) Standard Deviation 218.52
Dose Exploration Period: Level of Circulating T Cells and Natural Killer (NK) Cells NK cells	266.5 cells/microliter (µL) Standard Deviation 182.97	237.76 cells/microliter (µL) Standard Deviation 118.63

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 24

Population: Safety evaluable population included all participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.

Outcome measures

Measure	Body Weight < 40 kg n=5 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=13 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Level of Circulating Lymphocyte, Neutrophil, Monocyte and Leukocyte Lymphocyte	1.792 10^9 cells/L Standard Deviation 0.660	1.668 10^9 cells/L Standard Deviation 0.507
Dose Exploration Period: Level of Circulating Lymphocyte, Neutrophil, Monocyte and Leukocyte Neutrophil	2.60 10^9 cells/L Standard Deviation 0.567	2.857 10^9 cells/L Standard Deviation 0.762
Dose Exploration Period: Level of Circulating Lymphocyte, Neutrophil, Monocyte and Leukocyte Monocyte	0.328 10^9 cells/L Standard Deviation 0.151	0.343 10^9 cells/L Standard Deviation 0.114
Dose Exploration Period: Level of Circulating Lymphocyte, Neutrophil, Monocyte and Leukocyte Leukocyte	4.87 10^9 cells/L Standard Deviation 1.35	5.05 10^9 cells/L Standard Deviation 1.06

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety evaluable population included all participants who received at least one dose of study drug.

The change in the non-MS CNS pathology was assessed using MRI scans.

Outcome measures

Measure	Body Weight < 40 kg n=6 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=17 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Number of Participants With Shift From Baseline in Non-MS Central Nervous System (CNS) Pathology as Measured by Brain Magnetic Resonance Imaging (MRI)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 24

Population: Safety evaluable population included all participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis at specified timepoint.

Outcome measures

Measure	Body Weight < 40 kg n=4 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=14 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Levels of Blood Immunoglobulins Total Immunoglobulin	11.23 gram/liter (g/L) Standard Deviation 1.40	11.86 gram/liter (g/L) Standard Deviation 2.92
Dose Exploration Period: Levels of Blood Immunoglobulins Immunoglobulin A	1.27 gram/liter (g/L) Standard Deviation 0.48	1.52 gram/liter (g/L) Standard Deviation 0.61
Dose Exploration Period: Levels of Blood Immunoglobulins Immunoglobulin G	9.25 gram/liter (g/L) Standard Deviation 1.20	9.73 gram/liter (g/L) Standard Deviation 2.51
Dose Exploration Period: Levels of Blood Immunoglobulins Immunoglobulin M	0.72 gram/liter (g/L) Standard Deviation 0.26	0.61 gram/liter (g/L) Standard Deviation 0.31

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 24

Population: Safety evaluable population included all participants who received at least one dose of study drug.

Measurement of antibody titers to common antigens (mumps, rubella, varicella, and Streptococcus pneumoniae [S. pneumoniae]) were performed.

Outcome measures

Measure	Body Weight < 40 kg n=6 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=17 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Number of Participants With Antibody Titers Against Standard Vaccines Mumps	0 Participants	0 Participants
Dose Exploration Period: Number of Participants With Antibody Titers Against Standard Vaccines Pneumococcal Capsular Polysaccharides	6 Participants	17 Participants
Dose Exploration Period: Number of Participants With Antibody Titers Against Standard Vaccines Rubella	0 Participants	0 Participants
Dose Exploration Period: Number of Participants With Antibody Titers Against Standard Vaccines Varicella-Zoster Virus	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 24

Population: Safety evaluable population included all participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis at specified timepoint.

Outcome measures

Measure	Body Weight < 40 kg n=6 Participants Participants who weighed \< 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15.	Body Weight ≥ 40 kg n=17 Participants Participants who weighed ≥ 40 kg were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15.
Dose Exploration Period: Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

Adverse Events

Ocrelizumab 300 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Ocrelizumab 600 mg

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ocrelizumab 300 mg n=6 participants at risk Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.	Ocrelizumab 600 mg n=17 participants at risk Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Peripheral swelling	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Abscess limb	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Appendicitis	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Candida infection	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Gonococcal infection	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Pneumonia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Psychiatric disorders Conversion disorder	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Vascular disorders Hypotension	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.

Other adverse events

Measure	Ocrelizumab 300 mg n=6 participants at risk Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.	Ocrelizumab 600 mg n=17 participants at risk Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.
Cardiac disorders Bundle branch block left	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Cardiac disorders Tachycardia	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Endocrine disorders Hyperprolactinaemia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Eye disorders Chalazion	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Eye disorders Eye pain	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Abdominal pain	33.3% 2/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Defaecation urgency	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Dental caries	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	23.5% 4/17 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Temperature intolerance	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Immune system disorders Hypersensitivity	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Mouth ulceration	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Nausea	33.3% 2/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Asthenia	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Chest pain	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Fatigue	33.3% 2/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	17.6% 3/17 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Influenza like illness	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Malaise	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Peripheral swelling	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
General disorders Pyrexia	33.3% 2/6 • Number of events 5 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	35.3% 6/17 • Number of events 7 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Blood and lymphatic system disorders Monocytopenia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Adenovirus infection	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Anal abscess	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Bacterial infection	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Bacterial vaginosis	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations COVID-19	50.0% 3/6 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	64.7% 11/17 • Number of events 11 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Fungal infection	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Gastroenteritis	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Gastrointestinal infection	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Herpes virus infection	16.7% 1/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Herpes zoster	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Influenza	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Nasal herpes	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	41.2% 7/17 • Number of events 11 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Oral herpes	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Pharyngitis	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	17.6% 3/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Rhinitis	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Tooth abscess	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Tooth infection	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	35.3% 6/17 • Number of events 8 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Urinary tract infection	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Viral infection	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	17.6% 3/17 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Concussion	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Fall	16.7% 1/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Immunisation reaction	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Infusion related reaction	50.0% 3/6 • Number of events 5 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	82.4% 14/17 • Number of events 45 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Limb injury	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Product preparation error	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Torus fracture	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Injury, poisoning and procedural complications Upper limb fracture	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Blood immunoglobulin G decreased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Blood immunoglobulin M decreased	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Blood lactate dehydrogenase increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Blood triglycerides increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations CD4 lymphocytes decreased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations CD8 lymphocytes decreased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Electrocardiogram QT prolonged	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Fungal test positive	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Gamma-glutamyltransferase increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations International normalised ratio increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Lipase increased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Lymphocyte count decreased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Monocyte count decreased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Neutrophil count decreased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Protein urine present	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Urine output decreased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Vitamin D decreased	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Investigations Weight decreased	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Metabolism and nutrition disorders Vitamin D deficiency	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	17.6% 3/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Brain fog	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Cognitive disorder	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Decreased vibratory sense	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Disturbance in attention	33.3% 2/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Dizziness	33.3% 2/6 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	23.5% 4/17 • Number of events 5 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Dizziness postural	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Dysarthria	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Facial paresis	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Headache	33.3% 2/6 • Number of events 12 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	47.1% 8/17 • Number of events 29 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Migraine	16.7% 1/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	17.6% 3/17 • Number of events 5 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Nervous system disorder	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Paraesthesia	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Presyncope	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Sensory loss	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Nervous system disorders Tremor	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	23.5% 4/17 • Number of events 4 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Psychiatric disorders Conversion disorder	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Psychiatric disorders Initial insomnia	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Psychiatric disorders Mood altered	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Psychiatric disorders Restlessness	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Renal and urinary disorders Micturition urgency	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	29.4% 5/17 • Number of events 5 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Skin and subcutaneous tissue disorders Acne	16.7% 1/6 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	0.00% 0/17 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 2 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Surgical and medical procedures Wisdom teeth removal	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	11.8% 2/17 • Number of events 3 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Vascular disorders Hypertension	0.00% 0/6 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.	5.9% 1/17 • Number of events 1 • Up to 3.7 years Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

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