Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (NCT NCT04035005)
NCT ID: NCT04035005
Last Updated: 2026-02-23
Results Overview
Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (EDSS) score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1013 participants
Primary outcome timeframe
Up to approximately 243 weeks
Results posted on
2026-02-23
Participant Flow
A total of 1013 participants with primary progressive multiple sclerosis (PPMS) took part in the study at 148 investigative sites across 23 countries. Participants were randomized in a 1:1 ratio to receive double-blinded treatment (DBT) with either ocrelizumab or placebo followed by an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), \& follow-up 2 (FU2).
1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis. The study is still ongoing.
Participant milestones
| Measure |
Ocrelizumab
Participants received the first dose of ocrelizumab as two 300 milligrams (mg) intravenous (IV) infusions, administered 14 days apart. Thereafter, participants received ocrelizumab 600 mg as a single IV infusion every 24 weeks (Q24W) for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a double-progression event (DPE) during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
DBT
STARTED
|
505
|
508
|
|
DBT
Safety Analysis Set (SAS)
|
506
|
506
|
|
DBT
COMPLETED
|
321
|
273
|
|
DBT
NOT COMPLETED
|
184
|
235
|
|
PDP OCR Treatment Phase
STARTED
|
9
|
31
|
|
PDP OCR Treatment Phase
COMPLETED
|
0
|
0
|
|
PDP OCR Treatment Phase
NOT COMPLETED
|
9
|
31
|
|
FU1 Phase
STARTED
|
8
|
7
|
|
FU1 Phase
COMPLETED
|
2
|
1
|
|
FU1 Phase
NOT COMPLETED
|
6
|
6
|
|
OCR OLE Phase
STARTED
|
321
|
273
|
|
OCR OLE Phase
COMPLETED
|
0
|
0
|
|
OCR OLE Phase
NOT COMPLETED
|
321
|
273
|
|
FU2 Phase
STARTED
|
4
|
3
|
|
FU2 Phase
COMPLETED
|
0
|
1
|
|
FU2 Phase
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Ocrelizumab
Participants received the first dose of ocrelizumab as two 300 milligrams (mg) intravenous (IV) infusions, administered 14 days apart. Thereafter, participants received ocrelizumab 600 mg as a single IV infusion every 24 weeks (Q24W) for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a double-progression event (DPE) during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
DBT
Ongoing in DBT
|
108
|
109
|
|
DBT
Adverse Event
|
8
|
6
|
|
DBT
Death
|
11
|
9
|
|
DBT
Lack of Efficacy
|
1
|
2
|
|
DBT
Lost to Follow-up
|
3
|
5
|
|
DBT
Reason not Specified
|
0
|
1
|
|
DBT
Physician Decision
|
0
|
5
|
|
DBT
Protocol Violation
|
0
|
1
|
|
DBT
Switch to Commercial Ocrelizumab
|
1
|
4
|
|
DBT
Withdrawal by Subject
|
35
|
55
|
|
DBT
Discontinued and Entered PDP OCR Treatment Phase
|
9
|
31
|
|
DBT
Discontinued and Entered FU1 Phase
|
8
|
7
|
|
PDP OCR Treatment Phase
Ongoing in PDP OCR Phase
|
6
|
26
|
|
PDP OCR Treatment Phase
Discontinued and Entered FU2
|
0
|
1
|
|
PDP OCR Treatment Phase
Death
|
1
|
0
|
|
PDP OCR Treatment Phase
Withdrawal by Subject
|
1
|
4
|
|
PDP OCR Treatment Phase
Physician Decision
|
1
|
0
|
|
FU1 Phase
Ongoing in FU1 Phase
|
2
|
2
|
|
FU1 Phase
Death
|
0
|
1
|
|
FU1 Phase
Lost to Follow-up
|
1
|
0
|
|
FU1 Phase
Withdrawal by Subject
|
3
|
3
|
|
OCR OLE Phase
Ongoing in OLE Phase
|
309
|
261
|
|
OCR OLE Phase
Adverse Event
|
1
|
1
|
|
OCR OLE Phase
Death
|
3
|
4
|
|
OCR OLE Phase
Lost to Follow-up
|
0
|
1
|
|
OCR OLE Phase
Withdrawal by Subject
|
6
|
5
|
|
OCR OLE Phase
Discontinued and Entered FU2
|
2
|
1
|
|
FU2 Phase
Ongoing in FU2 Phase
|
2
|
2
|
|
FU2 Phase
Death
|
1
|
0
|
|
FU2 Phase
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Ocrelizumab
n=505 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=508 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Total
n=1013 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 10.5 • n=58 Participants
|
47.1 years
STANDARD_DEVIATION 10.6
|
47.4 years
STANDARD_DEVIATION 10.6 • n=1 Participants
|
|
Sex: Female, Male
Female
|
290 Participants
n=58 Participants
|
278 Participants
|
568 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
215 Participants
n=58 Participants
|
230 Participants
|
445 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=58 Participants
|
22 Participants
|
53 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
457 Participants
n=58 Participants
|
476 Participants
|
933 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=58 Participants
|
10 Participants
|
27 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=58 Participants
|
14 Participants
|
32 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=58 Participants
|
2 Participants
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=58 Participants
|
0 Participants
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=58 Participants
|
1 Participants
|
3 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
464 Participants
n=58 Participants
|
480 Participants
|
944 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=58 Participants
|
4 Participants
|
8 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=58 Participants
|
7 Participants
|
22 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 243 weeksPopulation: FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis.
Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (EDSS) score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
Outcome measures
| Measure |
Ocrelizumab
n=504 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=507 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS
|
204.9 weeks
Interval 141.1 to
The upper limit of 95% confidence interval (CI) was not estimable due to an insufficient number of participants with event.
|
133.6 weeks
Interval 121.9 to 168.1
|
PRIMARY outcome
Timeframe: Up to approximately 243 weeksPopulation: MRI activity analysis set included all randomized participants with MRI activity, defined as the presence of T1 gadolinium-enhanced (Gd+) lesion(s) at baseline and/or new and/or enlarging T2 lesion(s) as detected by MRI scans during the screening phase. Participants were grouped according to the treatment assigned at randomization.
Time to onset of cCDP12 was defined as the time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in EDSS score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
Outcome measures
| Measure |
Ocrelizumab
n=183 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=185 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set
|
NA weeks
The median and 95% CI were not estimable due to an insufficient number of participants with events.
|
124.9 weeks
Interval 103.3 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Up to approximately 243 weeksPopulation: FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis.
12-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the total time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
Outcome measures
| Measure |
Ocrelizumab
n=504 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=507 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Time to 12-week CDP in 9-HPT
|
204.9 weeks
The 95% CI was not estimable due to an insufficient number of participants with event.
|
203.3 weeks
Interval 168.1 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Up to approximately 243 weeksPopulation: FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis.
12-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 12 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated \& then scored as a functional system scores (FSS), \& ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0-5/6, \& ambulation score that is rated from 0 to 16. These ratings along with observations \& assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.
Outcome measures
| Measure |
Ocrelizumab
n=504 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=507 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Time to 12-week CDP in EDSS
|
NA weeks
The median and 95% CI were not estimable due to an insufficient number of participants with event.
|
155.7 weeks
Interval 146.0 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Up to approximately 243 weeksPopulation: FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis.
24-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 24 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the amount of time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
Outcome measures
| Measure |
Ocrelizumab
n=504 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=507 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Time to 24-week CDP in 9-HPT
|
180.1 weeks
Interval 180.1 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with event.
|
203.3 weeks
Interval 168.1 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Up to approximately 243 weeksPopulation: FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis.
24-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 24 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated and then scored as a FSS, and ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0 to 5 or 6, and ambulation score that is rated from 0 to 16. These ratings along with observations and assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.
Outcome measures
| Measure |
Ocrelizumab
n=504 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=507 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Time to 24-week CDP in EDSS
|
NA weeks
The median and 95% CI were not estimable due to an insufficient number of participants with event.
|
155.7 weeks
Interval 146.0 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Up to approximately 120 weeksPopulation: FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis.
Volume of T2 lesions was measured using MRI scans. Mean difference in annual rate of change from baseline in radius of total volume of T2 lesions between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS disease-modifying treatment (DMT) or commercial ocrelizumab occurred, is reported. Random Coefficient Regression (RCRM) Model was used to estimate annual rate of change.
Outcome measures
| Measure |
Ocrelizumab
n=484 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=478 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Annual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions
|
-0.016 centimeter (cm) per year
Interval -0.021 to -0.01
|
0.021 centimeter (cm) per year
Interval 0.013 to 0.029
|
SECONDARY outcome
Timeframe: From Week 24 up to approximately 120 weeksPopulation: FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis.
Brain volume was measured using MRI scans. Mean difference in annual rate of percent change from Week 24 in total brain volume between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS DMT or commercial ocrelizumab occurred, is reported. RCRM Model was used to estimate annual rate of change.
Outcome measures
| Measure |
Ocrelizumab
n=382 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=378 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Annual Rate of Percent Change From Week 24 in Total Brain Volume
|
-0.566 percent change per year
Interval -0.654 to -0.477
|
-0.564 percent change per year
Interval -0.66 to -0.468
|
SECONDARY outcome
Timeframe: From initiation of study drug up to approximately 10.5 yearsAE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any AE that is: Fatal; Life-threatening; Requires or prolongs inpatient hospitalization; Results in persistent or significant disability/incapacity; A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug OR a significant medical event in the investigator's judgment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 10.5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228Population: SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Outcome measures
| Measure |
Ocrelizumab
n=505 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=506 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
B-cell Levels in Blood
Baseline
|
221.20 cells/microliters (cells/μL)
Standard Deviation 122.80
|
212.09 cells/microliters (cells/μL)
Standard Deviation 117.06
|
|
B-cell Levels in Blood
Week 2
|
0.98 cells/microliters (cells/μL)
Standard Deviation 7.78
|
207.07 cells/microliters (cells/μL)
Standard Deviation 114.54
|
|
B-cell Levels in Blood
Week 12
|
14.57 cells/microliters (cells/μL)
Standard Deviation 53.95
|
252.58 cells/microliters (cells/μL)
Standard Deviation 83.48
|
|
B-cell Levels in Blood
Week 24
|
9.31 cells/microliters (cells/μL)
Standard Deviation 26.22
|
206.19 cells/microliters (cells/μL)
Standard Deviation 117.72
|
|
B-cell Levels in Blood
Week 36
|
35.73 cells/microliters (cells/μL)
Standard Deviation 50.79
|
232.94 cells/microliters (cells/μL)
Standard Deviation 156.34
|
|
B-cell Levels in Blood
Week 48
|
7.59 cells/microliters (cells/μL)
Standard Deviation 22.66
|
200.35 cells/microliters (cells/μL)
Standard Deviation 108.76
|
|
B-cell Levels in Blood
Week 60
|
36.08 cells/microliters (cells/μL)
Standard Deviation 61.01
|
217.64 cells/microliters (cells/μL)
Standard Deviation 150.79
|
|
B-cell Levels in Blood
Week 72
|
7.55 cells/microliters (cells/μL)
Standard Deviation 26.75
|
196.81 cells/microliters (cells/μL)
Standard Deviation 110.00
|
|
B-cell Levels in Blood
Week 84
|
15.04 cells/microliters (cells/μL)
Standard Deviation 30.10
|
219.46 cells/microliters (cells/μL)
Standard Deviation 135.10
|
|
B-cell Levels in Blood
Week 96
|
8.03 cells/microliters (cells/μL)
Standard Deviation 26.25
|
197.81 cells/microliters (cells/μL)
Standard Deviation 112.76
|
|
B-cell Levels in Blood
Week 108
|
27.66 cells/microliters (cells/μL)
Standard Deviation 57.90
|
205.44 cells/microliters (cells/μL)
Standard Deviation 90.71
|
|
B-cell Levels in Blood
Week 120
|
9.36 cells/microliters (cells/μL)
Standard Deviation 42.94
|
202.21 cells/microliters (cells/μL)
Standard Deviation 126.00
|
|
B-cell Levels in Blood
Week 132
|
13.93 cells/microliters (cells/μL)
Standard Deviation 39.57
|
200.75 cells/microliters (cells/μL)
Standard Deviation 105.92
|
|
B-cell Levels in Blood
Week 144
|
3.48 cells/microliters (cells/μL)
Standard Deviation 8.38
|
192.82 cells/microliters (cells/μL)
Standard Deviation 80.97
|
|
B-cell Levels in Blood
Week 156
|
4.50 cells/microliters (cells/μL)
Standard Deviation 0.71
|
215.00 cells/microliters (cells/μL)
Standard Deviation 59.40
|
|
B-cell Levels in Blood
Week 168
|
0.00 cells/microliters (cells/μL)
Standard Deviation NA
Standard deviation (SD) was not estimable for 1 participant.
|
152.67 cells/microliters (cells/μL)
Standard Deviation 94.65
|
|
B-cell Levels in Blood
Week 180
|
36.00 cells/microliters (cells/μL)
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
|
B-cell Levels in Blood
Week 192
|
—
|
135.00 cells/microliters (cells/μL)
Standard Deviation NA
SD was not estimable for 1 participant.
|
|
B-cell Levels in Blood
Week 204
|
259.00 cells/microliters (cells/μL)
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
|
B-cell Levels in Blood
Week 228
|
0.00 cells/microliters (cells/μL)
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228Population: SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Outcome measures
| Measure |
Ocrelizumab
n=460 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=467 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Change From Baseline in B-cell Levels
Change at Week 36
|
-206.70 cells/μL
Standard Deviation 101.74
|
-9.65 cells/μL
Standard Deviation 100.67
|
|
Change From Baseline in B-cell Levels
Change at Week 48
|
-216.97 cells/μL
Standard Deviation 118.30
|
-10.11 cells/μL
Standard Deviation 78.67
|
|
Change From Baseline in B-cell Levels
Change at Week 60
|
-209.92 cells/μL
Standard Deviation 109.68
|
-7.19 cells/μL
Standard Deviation 146.55
|
|
Change From Baseline in B-cell Levels
Change at Week 72
|
-220.87 cells/μL
Standard Deviation 122.14
|
-7.43 cells/μL
Standard Deviation 83.34
|
|
Change From Baseline in B-cell Levels
Change at Week 84
|
-206.36 cells/μL
Standard Deviation 98.52
|
-19.54 cells/μL
Standard Deviation 83.21
|
|
Change From Baseline in B-cell Levels
Change at Week 96
|
-223.86 cells/μL
Standard Deviation 124.29
|
-9.29 cells/μL
Standard Deviation 94.36
|
|
Change From Baseline in B-cell Levels
Change at Week 108
|
-197.66 cells/μL
Standard Deviation 122.00
|
-44.65 cells/μL
Standard Deviation 130.97
|
|
Change From Baseline in B-cell Levels
Change at Week 120
|
-216.28 cells/μL
Standard Deviation 126.33
|
-1.99 cells/μL
Standard Deviation 90.39
|
|
Change From Baseline in B-cell Levels
Change at Week 132
|
-243.00 cells/μL
Standard Deviation 144.23
|
-18.23 cells/μL
Standard Deviation 117.14
|
|
Change From Baseline in B-cell Levels
Change at Week 144
|
-227.07 cells/μL
Standard Deviation 106.36
|
-24.94 cells/μL
Standard Deviation 55.75
|
|
Change From Baseline in B-cell Levels
Change at Week 156
|
-206.50 cells/μL
Standard Deviation 161.93
|
-60.00 cells/μL
Standard Deviation 76.37
|
|
Change From Baseline in B-cell Levels
Change at Week 168
|
-282.00 cells/μL
Standard Deviation NA
SD was not estimable for 1 participant.
|
-127.67 cells/μL
Standard Deviation 68.54
|
|
Change From Baseline in B-cell Levels
Change at Week 180
|
-60.00 cells/μL
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
|
Change From Baseline in B-cell Levels
Change at Week 192
|
—
|
-104.00 cells/μL
Standard Deviation NA
SD was not estimable for 1 participant.
|
|
Change From Baseline in B-cell Levels
Change at Week 204
|
-278.00 cells/μL
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
|
Change From Baseline in B-cell Levels
Change at Week 228
|
-537.00 cells/μL
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
|
Change From Baseline in B-cell Levels
Change at Week 24
|
-210.92 cells/μL
Standard Deviation 118.65
|
-2.12 cells/μL
Standard Deviation 91.17
|
|
Change From Baseline in B-cell Levels
Change at Week 2
|
-218.56 cells/μL
Standard Deviation 121.25
|
-3.18 cells/μL
Standard Deviation 74.88
|
|
Change From Baseline in B-cell Levels
Change at Week 12
|
-208.29 cells/μL
Standard Deviation 124.70
|
9.33 cells/μL
Standard Deviation 60.64
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228Population: SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Percentages have been rounded off.
Outcome measures
| Measure |
Ocrelizumab
n=505 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=506 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Baseline
|
0.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 2
|
98.9 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 12
|
92.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 24
|
78.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 36
|
42.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 48
|
84.2 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 60
|
50.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 72
|
84.0 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 84
|
66.7 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 96
|
83.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 108
|
61.5 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 120
|
84.3 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 132
|
79.7 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 144
|
89.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 156
|
100 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 168
|
100 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 180
|
0 percentage of participants
|
—
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 192
|
—
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 204
|
0 percentage of participants
|
—
|
|
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Week 228
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228Population: SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Percentages have been rounded off.
Outcome measures
| Measure |
Ocrelizumab
n=505 Participants
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=506 Participants
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Baseline
|
1.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 2
|
99.6 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 12
|
92.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 24
|
85.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 36
|
51.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 48
|
87.3 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 60
|
58.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 72
|
89.4 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 84
|
75.6 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 96
|
88.5 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 108
|
69.2 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 120
|
88.8 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 132
|
83.1 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 144
|
89.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 156
|
100 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 168
|
100 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 180
|
0 percentage of participants
|
—
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 192
|
—
|
0 percentage of participants
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 204
|
0 percentage of participants
|
—
|
|
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Week 228
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 10.5 yearsPrevalence of ADAs at baseline is defined as the number of participants that is ADA positive at baseline. For determining post-baseline incidence, participants are considered to be ADA-positive if they are ADA-negative or have missing data at baseline but develop an ADA response following study drug exposure, or if they are ADA-positive at baseline and the titer of 1 or more post-baseline samples is at least 0.60 titer unit (t.u.) greater than the baseline titer result.
Outcome measures
Outcome data not reported
Adverse Events
Ocrelizumab
Serious events: 65 serious events
Other events: 257 other events
Deaths: 16 deaths
Placebo
Serious events: 68 serious events
Other events: 201 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Ocrelizumab
n=506 participants at risk
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=506 participants at risk
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.59%
3/506 • Number of events 3 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Haematochezia
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
General disorders
General physical health deterioration
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.40%
2/506 • Number of events 2 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
General disorders
Sudden cardiac death
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Hepatobiliary disorders
Gallbladder fistula
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Arthritis bacterial
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
COVID-19
|
1.4%
7/506 • Number of events 8 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.6%
13/506 • Number of events 14 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
1.6%
8/506 • Number of events 8 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Cystitis
|
0.40%
2/506 • Number of events 2 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 2 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Human anaplasmosis
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Localised infection
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.79%
4/506 • Number of events 4 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.59%
3/506 • Number of events 3 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Pyelonephritis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.79%
4/506 • Number of events 4 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.79%
4/506 • Number of events 4 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Urosepsis
|
0.59%
3/506 • Number of events 3 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.79%
4/506 • Number of events 4 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.59%
3/506 • Number of events 3 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.40%
2/506 • Number of events 2 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.59%
3/506 • Number of events 3 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.40%
2/506 • Number of events 2 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.40%
2/506 • Number of events 2 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Central nervous system mass
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 2 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Hemiparesis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Motor dysfunction
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Multiple sclerosis
|
0.40%
2/506 • Number of events 2 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.59%
3/506 • Number of events 3 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Multiple sclerosis pseudo relapse
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.59%
3/506 • Number of events 3 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Progressive multiple sclerosis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Quadriparesis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Relapsing multiple sclerosis
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Seizure
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Psychiatric disorders
Adjustment disorder
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Psychiatric disorders
Completed suicide
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Reproductive system and breast disorders
Vaginal cyst
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.40%
2/506 • Number of events 3 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Surgical and medical procedures
Tracheal resection
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Vascular disorders
Orthostatic hypotension
|
0.20%
1/506 • Number of events 1 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
0.00%
0/506 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
Other adverse events
| Measure |
Ocrelizumab
n=506 participants at risk
Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
Placebo
n=506 participants at risk
Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
14.8%
75/506 • Number of events 80 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
11.1%
56/506 • Number of events 58 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
37/506 • Number of events 46 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
9.1%
46/506 • Number of events 58 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
30/506 • Number of events 33 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
4.2%
21/506 • Number of events 28 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
10.7%
54/506 • Number of events 119 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
11.7%
59/506 • Number of events 107 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
19.6%
99/506 • Number of events 153 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
4.2%
21/506 • Number of events 35 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
27/506 • Number of events 30 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
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4.9%
25/506 • Number of events 27 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
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Nervous system disorders
Headache
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9.5%
48/506 • Number of events 72 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
|
8.7%
44/506 • Number of events 66 • AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received. 1 participant randomized to the placebo group received a single dose of ocrelizumab \& was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment \& was not included in safety analysis.
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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