Trial Outcomes & Findings for Pharmacokinetics and Safety of Roledumab in RhD-negative Pregnant Women Carrying an RhD-positive Foetus (NCT NCT02287896)

Last Updated: 2020-07-13

Results Overview

The parameter was estimated through a population pharmacokinetic model, during which concentration data (ante- and postnatal) obtained after single IM or IV route dose of roledumab. All samples (ante- and postnatal samples for IM and IV route) will be used for population PK modeling.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

IM: Antenatal PK time points at T0, 48h, 120h, 9d, 29d,59d and Posnatal PK time points at TO, 3d,9d, 6 weeks IV: antenal PK time points at T0, 1h, 24h, 48h, 96-120h, 29d, 59d and Postnatal PK time points at T0, 3d, 9d, 6 weeks.

Results posted on

2020-07-13

Participant Flow

100 subjects were pre-screened in the pre-assigment period, only 62 subjects were included in the study.

Participant milestones

Participant milestones
Measure	IM Arm Roledumab Roledumab Open-label IM * Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IM anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IM postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage	IV Arm Roledumab Roledumab Open-label IV * Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IV anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IV postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage.
Screening Visit V1 STARTED	36	26
Screening Visit V1 COMPLETED	36	26
Screening Visit V1 NOT COMPLETED	0	0
First Injection Visit STARTED	36	26
First Injection Visit COMPLETED	36	26
First Injection Visit NOT COMPLETED	0	0
Second Injection Visit STARTED	36	26
Second Injection Visit COMPLETED	36	25
Second Injection Visit NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	IM Arm Roledumab Roledumab Open-label IM * Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IM anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IM postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage	IV Arm Roledumab Roledumab Open-label IV * Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IV anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IV postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage.
Second Injection Visit Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IM Arm Roledumab n=36 Participants Roledumab Open-label IM Dosage and frequency of administration: * Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IM anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IM postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage	IV Arm Roledumab n=26 Participants Roledumab Open-label IV Dosage and frequency of administration: * Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IV anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IV postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage.	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=36 Participants	0 Participants n=26 Participants	0 Participants n=62 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=36 Participants	26 Participants n=26 Participants	62 Participants n=62 Participants
Age, Categorical >=65 years	0 Participants n=36 Participants	0 Participants n=26 Participants	0 Participants n=62 Participants
Age, Continuous	31.0 years n=36 Participants	31.5 years n=26 Participants	31.0 years n=62 Participants
Sex: Female, Male Female	36 Participants n=36 Participants	26 Participants n=26 Participants	62 Participants n=62 Participants
Sex: Female, Male Male	0 Participants n=36 Participants	0 Participants n=26 Participants	0 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	36 participants n=36 Participants	26 participants n=26 Participants	62 participants n=62 Participants

PRIMARY outcome

Timeframe: IM: Antenatal PK time points at T0, 48h, 120h, 9d, 29d,59d and Posnatal PK time points at TO, 3d,9d, 6 weeks IV: antenal PK time points at T0, 1h, 24h, 48h, 96-120h, 29d, 59d and Postnatal PK time points at T0, 3d, 9d, 6 weeks.

Outcome measures

Outcome measures
Measure	Population PK (PKS1) n=60 Participants Single dose of Roledumab 300 μg has been administered for ante- and postnatal periods.	IV Arm Roledumab Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab. \- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.
CL/F : Apparent Clearance	0.0106 L/h Standard Error 5.91	—

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Population PK (PKS1) n=60 Participants Single dose of Roledumab 300 μg has been administered for ante- and postnatal periods.	IV Arm Roledumab Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab. \- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.
V2/F : Central Volume of Distribution	4.02 L Standard Error 4.98	—

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Population PK (PKS1) n=60 Participants Single dose of Roledumab 300 μg has been administered for ante- and postnatal periods.	IV Arm Roledumab Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab. \- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.
t 1/2 : Terminal Half-life	481.7 hour Standard Error 0	—

PRIMARY outcome

Timeframe: for IM:T0, 48h, 120h, 9 days, 29 days, 59 days and for IV T0, 1h, 24h, 48h, 96-120h, 29 days, 59 days

Population: In the IV arm (PKS3), the overall number of participants analyzed was 25. Due to a sensitizing event at late stage of pregnancy in one woman and a premature delivery in another woman, the number of subjects in the analyzed population was 23.

C max (maximum observed serum concentration) of Roledumab in all ITT subjects enrolled in the IM arm or the IV arm, who had at least one valid PK assessment after the first IMP administration, providing at least one evaluable PK parameter. Only samples post-first administration (antenatal samples) will be analyzed by NCA PK analysis for each study arm.

Outcome measures

Outcome measures
Measure	Population PK (PKS1) n=34 Participants Single dose of Roledumab 300 μg has been administered for ante- and postnatal periods.	IV Arm Roledumab n=23 Participants Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab. \- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.
C Max	21.6 ng/mL Interval 7.98 to 31.5	71.8 ng/mL Interval 42.9 to 91.5

PRIMARY outcome

Timeframe: for IM:T0, 48h, 120h, 9 days, 29 days, 59 days and for IV T0, 1h, 24h, 48h, 96-120h, 29 days, 59 days

T max (time of the maximum observed plasma concentration) of Roledumab in all ITT subjects enrolled in the IM arm or the IV arm, who had at least one valid PK assessment after the first IMP administration, providing at least one evaluable PK parameter. Only samples post-first administration (antenatal samples) will be analyzed by NCA PK analysis for each study arm.

Outcome measures

Outcome measures
Measure	Population PK (PKS1) n=34 Participants Single dose of Roledumab 300 μg has been administered for ante- and postnatal periods.	IV Arm Roledumab n=23 Participants Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab. \- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.
T Max	167.21 hour Interval 46.25 to 671.58	1.00 hour Interval 0.95 to 1.5

PRIMARY outcome

Timeframe: for IM:T0, 48h, 120h, 9 days, 29 days, 59 days and for IV: T0, 1h, 24h, 48h, 96-120h, 29 days, 59 days

Population: In the IM arm, the number of participants analyzed was 34, but only 28 subjects with AUCextrap \<30% were eligible. In the IV arm, the number of participants analyzed was 25. Due to a sensitizing event at late stage of pregnancy in one woman and a premature delivery in another woman, the number of subjects in the analyzed population was 23.

T 1/2 (apparent plasma terminal elimination half-life) of Roledumab in all ITT subjects enrolled in the IM arm or the IV arm, who had at least one valid PK assessment after the first IMP administration, providing at least one evaluable PK parameter. Only samples post-first administration (antenatal samples) will be analyzed by NCA PK analysis for each study arm.

Outcome measures

Outcome measures
Measure	Population PK (PKS1) n=28 Participants Single dose of Roledumab 300 μg has been administered for ante- and postnatal periods.	IV Arm Roledumab n=23 Participants Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab. \- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.
T 1/2	462 hour Interval 379.0 to 835.0	412 hour Interval 304.0 to 748.0

PRIMARY outcome

Timeframe: for IM: T0, 48h, 120h, 9 days, 29 days, 59 days and for IV T0, 1h, 24h, 48h, 96-120h, 29 days, 59 days

Population: In the IV arm, the number of participants analyzed was 25. Due to a sensitizing event at late stage of pregnancy in one woman and a premature delivery in another woman, the number of subjects in the analyzed population was 23.

AUC 0-t (area under the concentration-time curve from time 0 to time Tlast) of Roledumab in all ITT subjects enrolled in the IM arm or the IV arm, who had at least one valid PK assessment after the first IMP administration, providing at least one evaluable PK parameter. Only samples post-first administration (antenatal samples) will be analyzed by NCA PK analysis for each study arm.

Outcome measures

Outcome measures
Measure	Population PK (PKS1) n=34 Participants Single dose of Roledumab 300 μg has been administered for ante- and postnatal periods.	IV Arm Roledumab n=23 Participants Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab. \- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.
AUC 0-t	16600 h*ng/mL Interval 9450.0 to 25300.0	24900 h*ng/mL Interval 14300.0 to 38500.0

Adverse Events

IM Arm Roledumab

Serious events: 15 serious events

Other events: 36 other events

Deaths: 0 deaths

IV Arm Roledumab

Serious events: 9 serious events

Other events: 26 other events

Deaths: 0 deaths

All Patients

Serious events: 24 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical trial Information desk

LFB Biotechnologies

Phone: 33169825656

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	IM Arm Roledumab n=36 participants at risk Arm with RhD-negative pregnant women who were allocated to the IM route of administration of LFB-R593 Dosage and frequency of administration: * Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IM anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IM postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage	IV Arm Roledumab n=26 participants at risk Arm with RhD-negative pregnant women who were allocated to the IV route of administration of LFB-R593 Dosage and frequency of administration: * Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IV anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IV postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage.	All Patients n=62 participants at risk Arm with RhD-negative pregnant women who were allocated to the IV and the IM route of administration of LFB-R593
Injury, poisoning and procedural complications Abdominal injury	5.6% 2/36 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.2% 2/62 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Cardiac disorders Foetal heart rate disorder	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Congenital, familial and genetic disorders Poland's syndrome	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Congenital, familial and genetic disorders Polydactyly	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	5.6% 2/36 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	4.8% 3/62 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions preterm premature rupture of mebranes	5.6% 2/36 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.2% 2/62 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Prolonged rupture of membranes	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Retained placenta of membranes	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions premature baby	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.2% 2/62 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions HELLP sydrome	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Threatened labour	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
General disorders fever neonatal	5.6% 2/36 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.2% 2/62 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
General disorders Pyelocaliectasis	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Renal and urinary disorders Urinary retention	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Metabolism and nutrition disorders Hypoglycaemia	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Metabolism and nutrition disorders Feeding disorder	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Infections and infestations Amniotic cavity infection	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	0.00% 0/26 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Infections and infestations Neonatal infection	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.2% 2/62 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Infections and infestations Bronchiolitis	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	1.6% 1/62 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.

Other adverse events
Measure	IM Arm Roledumab n=36 participants at risk Arm with RhD-negative pregnant women who were allocated to the IM route of administration of LFB-R593 Dosage and frequency of administration: * Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IM anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IM postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage	IV Arm Roledumab n=26 participants at risk Arm with RhD-negative pregnant women who were allocated to the IV route of administration of LFB-R593 Dosage and frequency of administration: * Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation. * Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IV anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence. * Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant. The postnatal dose must still be given even when antenatal prophylaxis has been administered. Before Roledumab 300μg IV postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage.	All Patients n=62 participants at risk Arm with RhD-negative pregnant women who were allocated to the IV and the IM route of administration of LFB-R593
Investigations C reactive protein increased	11.1% 4/36 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	8.1% 5/62 • Number of events 5 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Blood and lymphatic system disorders Anaemia of pregnancy	30.6% 11/36 • Number of events 11 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	19.2% 5/26 • Number of events 7 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	25.8% 16/62 • Number of events 18 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Nervous system disorders Headache	30.6% 11/36 • Number of events 16 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	23.1% 6/26 • Number of events 8 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	27.4% 17/62 • Number of events 24 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Afterbirth pain	27.8% 10/36 • Number of events 10 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	38.5% 10/26 • Number of events 10 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	32.3% 20/62 • Number of events 20 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions prolonged labour	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	7.7% 2/26 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	8.1% 5/62 • Number of events 5 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions prolonged rupture of membranes	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	6.5% 4/62 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Uterine contractions abnormal	11.1% 4/36 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	8.1% 5/62 • Number of events 5 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions uterine contractions during pregnancy	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	15.4% 4/26 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.3% 7/62 • Number of events 7 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions caput succedaneum	11.1% 4/36 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	8.1% 5/62 • Number of events 5 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	5.6% 2/36 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.5% 3/26 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	8.1% 5/62 • Number of events 5 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	15.4% 4/26 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	6.5% 4/62 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
General disorders Asthenia	11.1% 4/36 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.5% 3/26 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.3% 7/62 • Number of events 7 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
General disorders Vessel puncture site haematoma	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	15.4% 4/26 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	6.5% 4/62 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
General disorders Injection site haematoma	0.00% 0/36 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	30.8% 8/26 • Number of events 8 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	12.9% 8/62 • Number of events 8 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Gastrointestinal disorders Constipation	19.4% 7/36 • Number of events 7 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	19.2% 5/26 • Number of events 6 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	19.4% 12/62 • Number of events 13 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Gastrointestinal disorders Haemorrhoids	16.7% 6/36 • Number of events 6 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	34.6% 9/26 • Number of events 10 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	24.2% 15/62 • Number of events 16 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	26.9% 7/26 • Number of events 7 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	16.1% 10/62 • Number of events 10 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Gastrointestinal disorders Infantile colic	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.5% 3/26 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	9.7% 6/62 • Number of events 6 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Gastrointestinal disorders Abdominal pain	5.6% 2/36 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.5% 3/26 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	8.1% 5/62 • Number of events 5 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Gastrointestinal disorders Dyspepsia	5.6% 2/36 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	15.4% 4/26 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	9.7% 6/62 • Number of events 6 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Gastrointestinal disorders Nausea	2.8% 1/36 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.5% 3/26 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	6.5% 4/62 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Reproductive system and breast disorders Nipple disorder	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	6.5% 4/62 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Musculoskeletal and connective tissue disorders Back pain	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	15.4% 4/26 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.3% 7/62 • Number of events 7 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 2/36 • Number of events 2 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.5% 3/26 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	8.1% 5/62 • Number of events 5 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Musculoskeletal and connective tissue disorders ligament pain	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	6.5% 4/62 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Infections and infestations Gastroenteritis	11.1% 4/36 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.5% 3/26 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.3% 7/62 • Number of events 7 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Infections and infestations nasopharyngitis	16.7% 6/36 • Number of events 6 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	19.2% 5/26 • Number of events 6 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	17.7% 11/62 • Number of events 12 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Infections and infestations Vulvovaginal mycotic infection	8.3% 3/36 • Number of events 3 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	15.4% 4/26 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	11.3% 7/62 • Number of events 7 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.
Infections and infestations Neonatal candida infection	11.1% 4/36 • Number of events 4 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	3.8% 1/26 • Number of events 1 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.	8.1% 5/62 • Number of events 5 • The safety of roledumab was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study. AEs in both mother and fetus/newborn were collected and recorded. The safety of roledumab was to be assessed during the third trimester of pregnancy and during the postnatal follow-up visits up to 12 months after delivery.