Trial Outcomes & Findings for A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy (NCT NCT04998812)
NCT ID: NCT04998812
Last Updated: 2026-04-15
Results Overview
The event rate (percentage of infants with B cell levels below LLN) and corresponding Clopper Pearson 95% CI were reported. B-cell reference ranges by week of life (absolute counts) are defined by Borriello et al. 2022.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
At Week 6 of infant's life
Results posted on
2026-04-15
Participant Flow
35 pregnant women (with singleton pregnancy) were enrolled in the study across 10 centers in the United States, Germany, France, Switzerland and Spain from 13 April 2022 to 14 July 2025. An Informed Consent Form (ICF) for participation of the maternal subject and her unborn was signed and dated by the subject. Where applicable, the written ICF with respect to the infant was also signed and dated by the holder of parental rights as designated by the maternal subject.
Pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) who were exposed accidentally or as part of routine clinical practice to commercial ocrelizumab up to 6 months before the last menstrual period (LMP) or during the first trimester of pregnancy were enrolled \& potential placental transfer of ocrelizumab in infants was observed.
Participant milestones
| Measure |
Women
Pregnant women receiving commercial ocrelizumab intravenously (IV) either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.
|
Infants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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.
|
|---|---|---|
|
Pregnancy and Early Post-Partum Period
STARTED
|
35
|
35
|
|
Pregnancy and Early Post-Partum Period
Subject Gave Birth/Infant Was Born
|
35
|
35
|
|
Pregnancy and Early Post-Partum Period
COMPLETED
|
33
|
34
|
|
Pregnancy and Early Post-Partum Period
NOT COMPLETED
|
2
|
1
|
|
Vaccination Period
STARTED
|
33
|
34
|
|
Vaccination Period
COMPLETED
|
32
|
33
|
|
Vaccination Period
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Women
Pregnant women receiving commercial ocrelizumab intravenously (IV) either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.
|
Infants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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.
|
|---|---|---|
|
Pregnancy and Early Post-Partum Period
Participant switches to another treatment of MS
|
1
|
0
|
|
Pregnancy and Early Post-Partum Period
Reason not Specified
|
1
|
1
|
|
Vaccination Period
Reason not Specified
|
1
|
1
|
Baseline Characteristics
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
Baseline characteristics by cohort
| Measure |
Women
n=35 Participants
Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.
|
Infants
n=35 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=193 Participants
|
35 Participants
n=193 Participants
|
35 Participants
n=386 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age <37 weeks)
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Customized
Adults (18-64 years)
|
35 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
35 Participants
n=386 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=193 Participants
|
22 Participants
n=193 Participants
|
57 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
13 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
35 Participants
n=193 Participants
|
35 Participants
n=193 Participants
|
70 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: At Week 6 of infant's lifePopulation: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.
The event rate (percentage of infants with B cell levels below LLN) and corresponding Clopper Pearson 95% CI were reported. B-cell reference ranges by week of life (absolute counts) are defined by Borriello et al. 2022.
Outcome measures
| Measure |
Infants
n=34 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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)
|
0 percentage of participants
Interval 0.0 to 10.28
|
SECONDARY outcome
Timeframe: At Week 6 of infant's lifePopulation: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
Infants
n=34 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Potentially Exposed to Ocrelizumab During Pregnancy
|
1170.00 cells per microliter (cells/µL)
Interval 269.0 to 2408.0
|
SECONDARY outcome
Timeframe: At Week 6 of infant's lifePopulation: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
Infants
n=34 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Potentially Exposed to Ocrelizumab During Pregnancy
|
19.20 percentage of cells
Interval 5.2 to 35.3
|
SECONDARY outcome
Timeframe: Within 1 hour after delivery (at birth, Day 1)Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy.
Serum ocrelizumab concentrations were measured in the umbilical cord blood at birth (within 1 hour after delivery) to evaluate whether there was placental transfer of ocrelizumab from the mother to the infant. At delivery, blood samples from the umbilical cord were collected. Ocrelizumab serum concentration below the lower limit of quantification (LLOQ = 156 ng/ml) was set to zero.
Outcome measures
| Measure |
Infants
n=35 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Umbilical Cord Blood at Birth
|
0.00 nanograms/milliliter (ng/mL)
Interval 0.0 to 694.0
|
SECONDARY outcome
Timeframe: At Week 6 of infant's lifePopulation: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.
Serum ocrelizumab concentrations were measured were measured at 6 weeks of the infants life to evaluate whether there was placental transfer of ocrelizumab from the mother to the infant. Serum samples from the infant were collected.
Outcome measures
| Measure |
Infants
n=33 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Week 6 of Life
|
0.00 ng/mL
Interval 0.0 to 263.0
|
SECONDARY outcome
Timeframe: Baseline (gestational Weeks 24-30), gestational Week 35, and at delivery (within 24 hours after delivery) (at birth, Day 1)Population: FASW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Serum concentration of ocrelizumab in the mother during pregnancy (time frame of blood sampling: Week 24-30, Week 35) and at delivery (time frame of blood sampling: within 24 hours after delivery). Ocrelizumab serum concentration below the lower limit of quantification (LLOQ = 156 ng/ml) was set to zero.
Outcome measures
| Measure |
Infants
n=35 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Mother
Baseline - Gestational Weeks 24-30
|
0.00 ng/mL
Interval 0.0 to 9090.0
|
|
Serum Concentration of Ocrelizumab in the Mother
Gestational Week 35
|
0.00 ng/mL
Interval 0.0 to 787.0
|
|
Serum Concentration of Ocrelizumab in the Mother
At Delivery
|
0.00 ng/mL
Interval 0.0 to 382.0
|
SECONDARY outcome
Timeframe: Up to approximately 71 weeksPopulation: Safety analysis set of infants (SAFI) included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy.
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. Percentages have been rounded off.
Outcome measures
| Measure |
Infants
n=35 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Adverse Events
|
82.9 percentage of infants
|
SECONDARY outcome
Timeframe: Up to approximately 87.6 weeksPopulation: Safety analysis set of women (SAFW) included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
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. Percentages have been rounded off.
Outcome measures
| Measure |
Infants
n=35 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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
|
94.3 percentage of mothers
|
SECONDARY outcome
Timeframe: At birth (Day 1)Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy.
Day 1 refers to the time an infant's birth.
Outcome measures
| Measure |
Infants
n=35 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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.
|
|---|---|
|
Infant Characteristics at Birth: Body Weight
|
3.46 kilogram (kg)
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: At birth (Day 1)Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.
Day 1 refers to the time an infant's birth.
Outcome measures
| Measure |
Infants
n=30 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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.
|
|---|---|
|
Infant Characteristics at Birth: Head Circumference
|
35.08 centimeter (cm)
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: At birth (Day 1)Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.
Day 1 refers to the time an infant's birth.
Outcome measures
| Measure |
Infants
n=33 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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.
|
|---|---|
|
Infant Characteristics at Birth: Body Length
|
51.58 cm
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: During pregnancy (anytime between 37 to 42 weeks of gestation) and at birth (at Day 1)Population: SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
Pregnancy outcomes analysed included live births (term and preterm, presence of congenital anomalies) and elective/therapeutic abortions and stillbirths.
Outcome measures
| Measure |
Infants
n=35 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth
Live Births
|
100 percentage of pregnancies
|
|
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth
Congenital Anomalies
|
8.6 percentage of pregnancies
|
|
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth
Therapeutic Abortions
|
0 percentage of pregnancies
|
|
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth
Stillbirth
|
0 percentage of pregnancies
|
|
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth
Preterm
|
0 percentage of pregnancies
|
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. Overall number analyzed are the number of infants with data available for analysis.
The immune response to MMR vaccination 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=28 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 MMR Vaccination
|
2697.43 mIU/mL
Standard Deviation 2124.74
|
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 vaccination 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=20 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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
|
94.37 RU/mL
Standard Deviation 62.56
|
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 vaccination 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=27 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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
|
137.57 IU/mL
Standard Deviation 96.30
|
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= number of infants with data available for specified IgG antibody titer.
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) are 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 U/mL; Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 IU/mL. Percentages have been rounded off.
Outcome measures
| Measure |
Infants
n=28 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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
Rubella, IgG
|
96.3 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to MMR Vaccination
Measles, IgG
|
96.4 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to MMR Vaccination
Mumps, IgG
|
90.0 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 vaccination 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=27 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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) Vaccination
|
1.02 IU/mL
Standard Deviation 1.35
|
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 vaccination 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=29 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Vaccination
|
1.45 COI
Standard Deviation 1.12
|
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 vaccination 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=19 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Vaccination
|
4.34 IU/mL
Standard Deviation 5.27
|
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 number of 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 DTP vaccine are as follows: Anti-Diphtheria IgG(-70)CL and Anti-Tetanus Toxoid IgG(-70)RUO: ≥ 0.01 IU/mL; Bordetella pertussis antibodies, IgG: \> 1.04 COI. 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 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=29 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Vaccination
Corynebacterium Diphtheriae, IgG
|
100 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to DTP Vaccination
Bordetella Pertussis, IgG
|
58.6 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to DTP Vaccination
Clostridium Tetani 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 vaccination 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=29 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Antibody Immune Responses to Haemophilus Influenzae Type B (Hib) Vaccination
|
2.99 microgram per milliliter (ug/mL)
Standard Deviation 3.55
|
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) will be presented for each 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=29 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Vaccination
|
82.8 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 vaccination will be 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 is not planned to be administered. This is to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Outcome measures
| Measure |
Infants
n=19 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Antibody Immune Responses to Hepatitis B Virus (HBV) Vaccination
|
2101.83 mIU/mL
Standard Deviation 3166.80
|
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=19 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Vaccination
|
94.7 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 vaccination 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=27 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 14, IgG
|
5.89 ug/mL
Standard Deviation 5.77
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 18C, IgG
|
3.29 ug/mL
Standard Deviation 5.15
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 19A, IgG
|
1.33 ug/mL
Standard Deviation 2.63
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 5, IgG
|
3.23 ug/mL
Standard Deviation 7.32
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 19F, IgG
|
14.01 ug/mL
Standard Deviation 33.90
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 23F, IgG
|
4.77 ug/mL
Standard Deviation 7.62
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 3, IgG
|
1.92 ug/mL
Standard Deviation 3.41
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 4, IgG
|
3.48 ug/mL
Standard Deviation 8.18
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 6A, IgG
|
10.42 ug/mL
Standard Deviation 19.67
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 6B, IgG
|
5.51 ug/mL
Standard Deviation 7.69
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 7F, IgG
|
3.06 ug/mL
Standard Deviation 3.44
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 9V, IgG
|
2.19 ug/mL
Standard Deviation 3.71
|
|
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 1, IgG
|
3.63 ug/mL
Standard Deviation 9.40
|
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. Percentages have been rounded off.
Outcome measures
| Measure |
Infants
n=27 Participants
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 9V, IgG
|
74.1 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 1, IgG
|
74.1 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 14, IgG
|
96.3 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 18C, IgG
|
77.8 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 19A, IgG
|
51.9 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 19F, IgG
|
92.6 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 23F, IgG
|
85.2 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 3, IgG
|
59.3 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 4, IgG
|
77.8 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 5, IgG
|
70.4 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 6A, IgG
|
92.6 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 6B, IgG
|
88.9 percentage of infants
|
|
Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination
Pneumococcal Capsular Polysaccharide, Serotype 7F, IgG
|
85.2 percentage of infants
|
Adverse Events
Women
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Infant
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Women
n=35 participants at risk
Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.
|
Infant
n=35 participants at risk
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Neonatal infection
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Post procedural infection
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Reproductive system and breast disorders
Uterine inflammation
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
Other adverse events
| Measure |
Women
n=35 participants at risk
Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.
|
Infant
n=35 participants at risk
Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice 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.
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|---|---|---|
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Gastrointestinal disorders
Constipation
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
14.3%
5/35 • Number of events 5 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
General disorders
Pyrexia
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
14.3%
5/35 • Number of events 8 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
8.6%
3/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
14.3%
5/35 • Number of events 5 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
COVID-19
|
22.9%
8/35 • Number of events 10 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
17.1%
6/35 • Number of events 6 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
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Infections and infestations
Conjunctivitis
|
8.6%
3/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
17.1%
6/35 • Number of events 6 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
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Infections and infestations
Ear infection
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
20.0%
7/35 • Number of events 8 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
4/35 • Number of events 7 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
20.0%
7/35 • Number of events 10 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Sinusitis
|
8.6%
3/35 • Number of events 4 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • Number of events 4 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.0%
7/35 • Number of events 8 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Injury, poisoning and procedural complications
Perineal injury
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
8.6%
3/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Investigations
Blood glucose increased
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Investigations
Blood immunoglobulin G decreased
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
14.3%
5/35 • Number of events 5 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • Number of events 5 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
11.4%
4/35 • Number of events 6 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
11.4%
4/35 • Number of events 5 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.4%
4/35 • Number of events 4 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
8.6%
3/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
11.4%
4/35 • Number of events 6 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Gastroenteritis
|
8.6%
3/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 3 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Influenza
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
2.9%
1/35 • Number of events 1 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Otitis media
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Infections and infestations
Subglottic laryngitis
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Musculoskeletal and connective tissue disorders
Head deformity
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Reproductive system and breast disorders
Perineal pain
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/35 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
5.7%
2/35 • Number of events 2 • Infants: Up to approximately 71 weeks Mothers: Up to approximately 87.6 weeks
Safety analysis was performed on SAFI and SAFW separately. SAFI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.
|
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