Trial Outcomes & Findings for Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS) (NCT NCT02688985)
NCT ID: NCT02688985
Last Updated: 2024-06-04
Results Overview
Primary Analysis was based on following data-cut off: Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Results posted on
2024-06-04
Participant Flow
131 patients enrolled at 17 study locations in the U.S., Canada, Germany, and Sweden
Participant milestones
| Measure |
RMS Cohort Arm 1: Ocrelizumab + LP
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 2: Ocrelizumab + LP
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 3: Ocrelizumab + LP
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 4: Ocrelizumab + LP
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
PPMS Cohort: Ocrelizumab + LP
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
31
|
28
|
18
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
23
|
31
|
28
|
18
|
30
|
Reasons for withdrawal
| Measure |
RMS Cohort Arm 1: Ocrelizumab + LP
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 2: Ocrelizumab + LP
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 3: Ocrelizumab + LP
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 4: Ocrelizumab + LP
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
PPMS Cohort: Ocrelizumab + LP
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
0
|
0
|
|
Overall Study
Continued Onto Commercially Available Ocrelizumab
|
12
|
12
|
14
|
14
|
21
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
1
|
1
|
|
Overall Study
Non-Compliance With Study Drug
|
1
|
3
|
1
|
0
|
1
|
|
Overall Study
Other
|
3
|
4
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
2
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
8
|
7
|
1
|
4
|
Baseline Characteristics
Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)
Baseline characteristics by cohort
| Measure |
RMS Cohort Arm 1: Ocrelizumab + LP
n=23 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 2: Ocrelizumab + LP
n=31 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 3: Ocrelizumab + LP
n=28 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 4: Ocrelizumab + LP
n=18 Participants
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
PPMS Cohort: Ocrelizumab + LP
n=31 Participants
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
131 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
36.0 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
38.7 Years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
34.6 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
36.4 Years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
44.9 Years
STANDARD_DEVIATION 7.4 • n=21 Participants
|
38.5 Years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
|
Sex/Gender, Customized
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Female
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
83 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
122 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
116 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)Population: The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus
Primary Analysis was based on following data-cut off: Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Outcome measures
| Measure |
RMS Cohort Arm 1: Ocrelizumab + LP
n=21 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 2: Ocrelizumab + LP
n=25 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 3: Ocrelizumab + LP
n=22 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 4: Ocrelizumab + LP
n=16 Participants
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
PPMS Cohort: Ocrelizumab + LP
n=28 Participants
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
|
|---|---|---|---|---|---|
|
Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Primary Analysis
|
-1232.97 pg/mL
Standard Deviation 2060.37
|
-1169.13 pg/mL
Standard Deviation 1739.49
|
-1008.13 pg/mL
Standard Deviation 1132.68
|
-931.83 pg/mL
Standard Deviation 2816.27
|
261.85 pg/mL
Standard Deviation 1175.72
|
|
Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
LTE phase Week 144
|
-2331.89 pg/mL
Standard Deviation 3334.80
|
-644.50 pg/mL
Standard Deviation 1371.39
|
-1287.58 pg/mL
Standard Deviation 1822.72
|
-2544.33 pg/mL
Standard Deviation 3807.94
|
-925.32 pg/mL
Standard Deviation 2507.97
|
|
Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
LTE phase Week 240
|
-2499.98 pg/mL
Standard Deviation 3606.71
|
-791.51 pg/mL
Standard Deviation 1150.89
|
-1060.33 pg/mL
Standard Deviation 1678.95
|
-5488.70 pg/mL
Standard Deviation 4350.46
|
-1221.33 pg/mL
Standard Deviation 2738.19
|
PRIMARY outcome
Timeframe: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)Population: The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Outcome measures
| Measure |
RMS Cohort Arm 1: Ocrelizumab + LP
n=21 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 2: Ocrelizumab + LP
n=25 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 3: Ocrelizumab + LP
n=22 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 4: Ocrelizumab + LP
n=16 Participants
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
PPMS Cohort: Ocrelizumab + LP
n=28 Participants
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
|
|---|---|---|---|---|---|
|
Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Primary Analysis
|
-0.22 cells/μL
Standard Deviation 0.26
|
-0.15 cells/μL
Standard Deviation 0.36
|
-0.13 cells/μL
Standard Deviation 0.32
|
-0.18 cells/μL
Standard Deviation 0.37
|
-0.09 cells/μL
Standard Deviation 0.11
|
|
Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
LTE phase Week 144
|
-0.11 cells/μL
Standard Deviation 0.08
|
-0.14 cells/μL
Standard Deviation 0.20
|
-0.06 cells/μL
Standard Deviation 0.23
|
0.15 cells/μL
Standard Deviation 0.10
|
-0.01 cells/μL
Standard Deviation 0.09
|
|
Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
LTE phase Week 240
|
-0.08 cells/μL
Standard Deviation 0.09
|
-0.20 cells/μL
Standard Deviation 0.26
|
-0.02 cells/μL
Standard Deviation 0.01
|
-0.04 cells/μL
Standard Deviation 0.05
|
0.01 cells/μL
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)Population: The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Outcome measures
| Measure |
RMS Cohort Arm 1: Ocrelizumab + LP
n=21 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 2: Ocrelizumab + LP
n=25 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 3: Ocrelizumab + LP
n=22 Participants
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 4: Ocrelizumab + LP
n=16 Participants
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
PPMS Cohort: Ocrelizumab + LP
n=28 Participants
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Primary Analysis
|
-6.61 cells/μL
Standard Deviation 10.48
|
-1.92 cells/μL
Standard Deviation 3.15
|
-1.46 cells/μL
Standard Deviation 2.67
|
-1.98 cells/μL
Standard Deviation 5.10
|
-3.25 cells/μL
Standard Deviation 4.32
|
|
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
LTE phase Week 144
|
-3.45 cells/μL
Standard Deviation 2.33
|
1.78 cells/μL
Standard Deviation 9.76
|
-0.83 cells/μL
Standard Deviation 4.64
|
2.25 cells/μL
Standard Deviation 0.17
|
-3.62 cells/μL
Standard Deviation 5.56
|
|
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
LTE phase Week 240
|
-3.00 cells/μL
Standard Deviation 3.16
|
-3.47 cells/μL
Standard Deviation 2.31
|
-1.41 cells/μL
Standard Deviation 1.30
|
-1.67 cells/μL
Standard Deviation 2.42
|
-1.37 cells/μL
Standard Deviation 0.54
|
Adverse Events
RMS Cohort Arm 1: Ocrelizumab + LP
Serious events: 5 serious events
Other events: 23 other events
Deaths: 1 deaths
RMS Cohort Arm 2: Ocrelizumab + LP
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
RMS Cohort Arm 3: Ocrelizumab + LP
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
RMS Cohort Arm 4: Ocrelizumab + LP
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
PPMS Cohort: Ocrelizumab + LP
Serious events: 9 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
RMS Cohort Arm 1: Ocrelizumab + LP
n=23 participants at risk
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 2: Ocrelizumab + LP
n=31 participants at risk
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 3: Ocrelizumab + LP
n=28 participants at risk
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 4: Ocrelizumab + LP
n=18 participants at risk
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
PPMS Cohort: Ocrelizumab + LP
n=31 participants at risk
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Appendicitis
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Cellulitis
|
4.3%
1/23 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Seronegative arthritis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Seizure
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Assisted suicide
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Completed suicide
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Mania
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
Other adverse events
| Measure |
RMS Cohort Arm 1: Ocrelizumab + LP
n=23 participants at risk
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 2: Ocrelizumab + LP
n=31 participants at risk
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 3: Ocrelizumab + LP
n=28 participants at risk
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
RMS Cohort Arm 4: Ocrelizumab + LP
n=18 participants at risk
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
|
PPMS Cohort: Ocrelizumab + LP
n=31 participants at risk
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Cardiac disorders
Palpitations
|
8.7%
2/23 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Cardiac disorders
Tachycardia
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Eye disorders
Eye pain
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Eye disorders
Vision blurred
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Anal incontinence
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
3/23 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.7%
3/18 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
14.3%
4/28 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.7%
3/18 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Chest discomfort
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Facial pain
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Fatigue
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
10.7%
3/28 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
22.2%
4/18 • Number of events 8 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.1%
5/31 • Number of events 10 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Gait disturbance
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Influenza like illness
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 6 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Oedema peripheral
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Pain
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Peripheral swelling
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Puncture site pain
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Pyrexia
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Immune system disorders
Seasonal allergy
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Bronchitis
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.1%
5/31 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
COVID-19
|
17.4%
4/23 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
22.2%
4/18 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.1%
5/31 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Conjunctivitis
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Ear infection
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Gastroenteritis
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Gastroenteritis viral
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Herpes zoster
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Impetigo
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
10.7%
3/28 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.1%
5/31 • Number of events 6 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Oral herpes
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Sinusitis
|
17.4%
4/23 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
32.3%
10/31 • Number of events 13 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
14.3%
4/28 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Tooth infection
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Upper respiratory tract infection
|
30.4%
7/23 • Number of events 10 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
19.4%
6/31 • Number of events 12 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
35.7%
10/28 • Number of events 19 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
66.7%
12/18 • Number of events 28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
41.9%
13/31 • Number of events 22 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Urinary tract infection
|
17.4%
4/23 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.1%
5/31 • Number of events 6 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
17.9%
5/28 • Number of events 9 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
38.9%
7/18 • Number of events 14 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
35.5%
11/31 • Number of events 41 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Viral infection
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.7%
3/18 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Fall
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
14.3%
4/28 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.1%
5/31 • Number of events 9 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
65.2%
15/23 • Number of events 36 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
29.0%
9/31 • Number of events 13 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
57.1%
16/28 • Number of events 32 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
61.1%
11/18 • Number of events 16 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
38.7%
12/31 • Number of events 38 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
8.7%
2/23 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
14.3%
4/28 • Number of events 7 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
22.2%
4/18 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
19.4%
6/31 • Number of events 8 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.3%
1/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
4.3%
1/23 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Investigations
Blood iron decreased
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Investigations
Body temperature increased
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Investigations
Influenza A virus test positive
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Investigations
Occult blood
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Investigations
Weight increased
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
14.3%
4/28 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
35.5%
11/31 • Number of events 14 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
22.2%
4/18 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
29.0%
9/31 • Number of events 10 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
10.7%
3/28 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
3/23 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
17.9%
5/28 • Number of events 6 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.7%
3/18 • Number of events 6 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 7 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Burning sensation
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
19.4%
6/31 • Number of events 10 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
14.3%
4/28 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
22.2%
4/18 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.1%
5/31 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Hypoaesthesia
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
14.3%
4/28 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 6 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Lhermitte's sign
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Migraine
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Multiple sclerosis
|
13.0%
3/23 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Multiple sclerosis pseudo relapse
|
13.0%
3/23 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Paraesthesia
|
13.0%
3/23 • Number of events 4 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
14.3%
4/28 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
12.9%
4/31 • Number of events 7 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Restless arm syndrome
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Nervous system disorders
Tremor
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Anxiety
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Depression
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
16.1%
5/31 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
10.7%
3/28 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Psychiatric disorders
Somnambulism
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
10.7%
3/28 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
11.1%
2/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
25.8%
8/31 • Number of events 8 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.7%
2/23 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
7.1%
2/28 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.2%
1/31 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
10.7%
3/28 • Number of events 5 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.3%
1/23 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
3.6%
1/28 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
6.5%
2/31 • Number of events 2 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/18 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
9.7%
3/31 • Number of events 3 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/23 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/28 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
5.6%
1/18 • Number of events 1 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
0.00%
0/31 • From baseline up to 5 years
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
|
Additional Information
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