Trial Outcomes & Findings for A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab (NCT NCT04998851)
NCT ID: NCT04998851
Last Updated: 2026-01-14
Results Overview
Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). The percentage of infants with B cell levels below LLN are reported with the two-sided Clopper Pearson 95% confidence interval (CI). B-cell reference ranges by week of life (absolute and percentage counts) are defined by Borriello et al. 2022.
COMPLETED
PHASE4
26 participants
At Day 30
2026-01-14
Participant Flow
A total of 13 mother-infant pairs took part in the study across 7 sites in the United States, Spain, and the United Kingdom from 16 September 2021 to 13 January 2025.
Lactating mothers with clinically isolated syndrome (CIS) or multiple sclerosis (MS) who, in consultation with their treating physician, chose to continue or start postpartum treatment with commercial ocrelizumab were enrolled in this study. This study included a 60-day treatment and sampling period followed by an 11-month vaccination period.
Participant milestones
| Measure |
Mothers
Lactating mothers initiating ocrelizumab received two doses of 300 milligrams (mg), as an intravenous (IV) infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.
|
Infants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of measles, mumps, and rubella (MMR) vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|---|
|
Treatment and Sampling Period (60 Days)
STARTED
|
13
|
13
|
|
Treatment and Sampling Period (60 Days)
COMPLETED
|
12
|
12
|
|
Treatment and Sampling Period (60 Days)
NOT COMPLETED
|
1
|
1
|
|
Vaccination Period (11 Months)
STARTED
|
12
|
12
|
|
Vaccination Period (11 Months)
COMPLETED
|
11
|
11
|
|
Vaccination Period (11 Months)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Mothers
Lactating mothers initiating ocrelizumab received two doses of 300 milligrams (mg), as an intravenous (IV) infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.
|
Infants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of measles, mumps, and rubella (MMR) vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|---|
|
Treatment and Sampling Period (60 Days)
Withdrawal by Subject
|
1
|
1
|
|
Vaccination Period (11 Months)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
Baseline characteristics by cohort
| Measure |
Mothers
n=13 Participants
Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.
|
Infants
n=13 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
From 65-84 years
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age <37 weeks)
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=14 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=24 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=14 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=24 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Adults (18-64 years)
|
13 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
13 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=14 Participants
|
6 Participants
n=10 Participants
|
19 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
13 Participants
n=14 Participants
|
13 Participants
n=10 Participants
|
26 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At Day 30Population: Full Analysis Set Infants (FASI) included all the infants of women in the FASM population. Overall number of participants analyzed is the number of participants with data available for analyses.
Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). The percentage of infants with B cell levels below LLN are reported with the two-sided Clopper Pearson 95% confidence interval (CI). B-cell reference ranges by week of life (absolute and percentage counts) are defined by Borriello et al. 2022.
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) Measured at Day 30 After the Mother's First Ocrelizumab Postpartum Infusion
|
0 percentage of participants
Interval 0.0 to 30.85
|
PRIMARY outcome
Timeframe: Up to Day 60Population: Pharmacokinetic Analysis Set Mothers (PASM) included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
ADID was calculated as the arithmetic mean of the mother's daily ocrelizumab milk concentration (micrograms/milliliters \[µg/mL\]) over 60 days post-ocrelizumab infusion 1 multiplied by an estimated infant milk intake of 150 milliliters/kilograms/day (mL/kg/day) and based on the weight \[kilograms (kg)\] recorded at the Day 30 visit. Ocrelizumab concentrations reported as below the lower limit of quantification \[LLQ=160 nanograms/millilitres (ng/mL)\] are imputed to zero for the calculation ADID.
Outcome measures
| Measure |
Infants
n=12 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Estimated Average Oral Daily Infant Dosage (ADID)
|
64.50 micrograms (µg)
Interval 21.415 to 107.587
|
SECONDARY outcome
Timeframe: At Day 30Population: FASI included all the infants of women in the FASM population. Overall number of participants analyzed is the number of participants with data available for analyses.
Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose).
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Absolute CD19+ B Cell Count in the Infant
|
1431.50 cells per microliter (cells/µL)
Interval 869.0 to 2241.0
|
SECONDARY outcome
Timeframe: At Day 30Population: FASI included all the infants of women in the FASM population. Overall number of participants analyzed is the number of participants with data available for analyses.
Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose).
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of CD19+ B Cell in the Infant
|
21.80 percentage of cells
Interval 10.0 to 31.7
|
SECONDARY outcome
Timeframe: One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
Outcome measures
| Measure |
Infants
n=12 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk
|
3.98 micrograms/millilitres*day (μg/mL*day)
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
Outcome measures
| Measure |
Infants
n=12 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Average Concentration of Ocrelizumab in Breastmilk (Cmean)
|
0.074 μg/mL
Standard Deviation 0.077
|
SECONDARY outcome
Timeframe: One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
Outcome measures
| Measure |
Infants
n=12 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk
|
0.18 μg/mL
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
Outcome measures
| Measure |
Infants
n=12 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk
|
3.97 days
Interval 0.0 to 59.9
|
SECONDARY outcome
Timeframe: Up to Day 60Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
MDID was calculated at the subject level as the peak ocrelizumab milk concentration (μg/mL) multiplied by an estimated infant milk intake of 150 mL/kg/day measured over 60 days after the mother's first postpartum ocrelizumab infusion.
Outcome measures
| Measure |
Infants
n=12 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Estimated Maximum Oral Daily Infant Dosage (MDID)
|
153.20 µg
Standard Deviation 137.15
|
SECONDARY outcome
Timeframe: Up to Day 60Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
Average RID over 60 days was calculated as the ADID (mg/kg/day) divided by the maternal dosage (mg/kg/day) over 60 days multiplied by 100.
Outcome measures
| Measure |
Infants
n=12 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Average Relative Infant Dose (RID)
|
0.50 percentage
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: At Day 30Population: Pharmacokinetic Analysis Set Infants (PASI) included all infants in the FASI with a serum sample to allow measurement of ocrelizumab concentration.
Serum concentration of ocrelizumab in the infant measured at Day 30 after the mother's first ocrelizumab postpartum infusion. Concentrations reported as below the lower limit of quantification (LLQ=156 ng/mL) are set to zero for calculation of summary statistics.
Outcome measures
| Measure |
Infants
n=9 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Serum Concentration of Ocrelizumab in the Infant at Day 30
|
NA µg/mL
Standard Deviation NA
Mean and standard deviation was not evaluable as the samples were below the limit of quantification (BLQ).
|
SECONDARY outcome
Timeframe: Up to approximately 73.3 weeks after first ocrelizumab dosePopulation: Safety Analysis Set Mothers (SAFM) included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. 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 (investigational) product, whether or not considered related to the medicinal (investigational) product.
Outcome measures
| Measure |
Infants
n=13 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of Mothers With Adverse Events (AEs)
|
76.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 73.3 weeks after first ocrelizumab dose administered to motherPopulation: Safety Analysis Set Infants (SAFI) included all the infants of women in the FASM population.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. 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 (investigational) product, whether or not considered related to the medicinal (investigational) product.
Outcome measures
| Measure |
Infants
n=13 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of Infants With AEs
|
92.3 percentage of infants
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: Antibody Immune Response Analysis Set of Infants (AIRI) included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available.
The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. mIU/mL=milli-international units per milliliter.
Outcome measures
| Measure |
Infants
n=11 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to Measles, Mumps, and Rubella (MMR) Vaccination
|
2590.91 mIU/mL
Standard Deviation 2210.74
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. RU/mL=relative units per milliliter.
Outcome measures
| Measure |
Infants
n=9 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Mumps, IgG Antibody in Response to MMR Vaccination
|
54.19 RU/mL
Standard Deviation 34.72
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. IU/mL=international units per milliliter.
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination
|
94.21 IU/mL
Standard Deviation 51.39
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Number analyzed refers to infants with data available for the specified IgG antibody titer.
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for MMR vaccine are as follows: Anti-Measles Vir IgG(-70)CL: ≥ 120 mIU/mL; Anti-MumpsAT Vir iGG(-70)CL: ≥ 17 RU/mL; Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 IU/mL.
Outcome measures
| Measure |
Infants
n=11 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of Infants With Positive Humoral Response to MMR Vaccination
Measles, IgG
|
100 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to MMR Vaccination
Mumps, IgG
|
77.8 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to MMR Vaccination
Rubella, IgG
|
100 percentage of infants
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccine
|
1.94 IU/mL
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows: * COI \< 0.95: Negative * COI 0.95-1.04: Equivocal * COI \> 1.04: Positive The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (\>1.04).
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Bordetella Pertussis, IgG Antibody in Response to DTP Vaccine
|
1.12 COI
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Outcome measures
| Measure |
Infants
n=6 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Tetanus Toxoid, IgG Antibody in Response to DTP Vaccine
|
1.23 IU/mL
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. Number analyzed refers to infants with data available for the specified IgG antibody titer.
The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows: * COI \< 0.95: Negative * COI 0.95-1.04: Equivocal * COI \> 1.04: Positive The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (\>1.04).
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of Infants With Positive Humoral Response to DTP Vaccine
Corynebacterium Diphtheriae, IgG
|
100 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to DTP Vaccine
Bordetella Pertussis, IgG
|
50 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to DTP Vaccine
Tetanus Toxoid, IgG
|
100 percentage of infants
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
The immune response to Hib vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Outcome measures
| Measure |
Infants
n=9 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Haemophilus Influenzae Type B (Hib), IgG Antibody in Response to Hib Vaccine
|
3.45 micrograms per milliliter (ug/mL)
Standard Deviation 4.21
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for Hib vaccine are as follows: Hib, IgG: ≥ 0.15 µg/mL.
Outcome measures
| Measure |
Infants
n=9 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of Infants With Positive Humoral Response to Hib Vaccine
|
88.9 percentage of infants
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
The immune response to HBV vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Outcome measures
| Measure |
Infants
n=7 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Anti-Hepatitis B Surface Antibody in Response to Hepatitis B Virus (HBV) Vaccine
|
1158.01 mIU/mL
Standard Deviation 1263.32
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for HBV vaccine are as follows: Anti-HBs: ≥ 10 mIU/mL.
Outcome measures
| Measure |
Infants
n=7 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of Infants With Positive Humoral Response to HBV Vaccine
|
100 percentage of infants
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
The immune response to PCV-13 vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 1, IgG
|
4.80 ug/mL
Standard Deviation 6.38
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 3, IgG
|
2.56 ug/mL
Standard Deviation 3.16
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 4, IgG
|
8.28 ug/mL
Standard Deviation 9.18
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 5, IgG
|
9.98 ug/mL
Standard Deviation 15.72
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 6A, IgG
|
27.28 ug/mL
Standard Deviation 34.50
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 6B, IgG
|
27.02 ug/mL
Standard Deviation 70.85
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 7F, IgG
|
9.44 ug/mL
Standard Deviation 14.11
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 9V, IgG
|
4.21 ug/mL
Standard Deviation 3.66
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 14, IgG
|
14.93 ug/mL
Standard Deviation 14.49
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 18C, IgG
|
9.62 ug/mL
Standard Deviation 11.47
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 19A, IgG
|
1.70 ug/mL
Standard Deviation 1.41
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 19F, IgG
|
45.83 ug/mL
Standard Deviation 80.11
|
|
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Pneumococcal Capsular Polysaccharide, Serotype 23F, IgG
|
10.50 ug/mL
Standard Deviation 13.17
|
SECONDARY outcome
Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for PCV-13 vaccine are as follows: 13 Valent anti-pneumococcal antibody panel: ≥ 0.35 µg/ml.
Outcome measures
| Measure |
Infants
n=10 Participants
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 1, IgG
|
80 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 3, IgG
|
70 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 4, IgG
|
80 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 5, IgG
|
90 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 6A, IgG
|
100 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 6B, IgG
|
80 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 7F, IgG
|
100 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 9V, IgG
|
90 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 14, IgG
|
100 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 18C, IgG
|
80 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 19A, IgG
|
60 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 19F, IgG
|
100 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13
Pneumococcal Capsular Polysaccharide, Serotype 23F, IgG
|
80 percentage of infants
|
Adverse Events
Mothers
Infants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mothers
n=13 participants at risk
Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.
|
Infants
n=13 participants at risk
Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.
|
|---|---|---|
|
Gastrointestinal disorders
Teething
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Gastrointestinal disorders
Oral pruritus
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Ear and labyrinth disorders
Vertigo positional
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Eye disorders
Strabismus
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
General disorders
Pain
|
15.4%
2/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
23.1%
3/13 • Number of events 3 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
15.4%
2/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
COVID-19
|
46.2%
6/13 • Number of events 6 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
30.8%
4/13 • Number of events 5 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Ear infection
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
23.1%
3/13 • Number of events 3 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
15.4%
2/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Mastitis
|
15.4%
2/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Nasopharyngitis
|
23.1%
3/13 • Number of events 4 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
23.1%
3/13 • Number of events 4 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Otitis media
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.4%
2/13 • Number of events 3 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
15.4%
2/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Vaginal infection
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Varicella
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
23.1%
3/13 • Number of events 3 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Investigations
Weight decreased
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Nervous system disorders
Multiple sclerosis pseudo relapse
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Nervous system disorders
Paraesthesia
|
15.4%
2/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
15.4%
2/13 • Number of events 3 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
15.4%
2/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Gastroenteritis viral
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Infected dermal cyst
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Tonsillitis
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
7.7%
1/13 • Number of events 2 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
7.7%
1/13 • Number of events 1 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
0.00%
0/13 • Mothers and Infants: Up to approximately 73.3 weeks
SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all the infants of women in the FASM population.
|
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