Trial Outcomes & Findings for Chloroquine for Malaria in Pregnancy (NCT NCT01443130)

Last Updated: 2016-12-28

Results Overview

The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

900 participants

Primary outcome timeframe

At delivery: Approximately 12-36 weeks after enrollment

Results posted on

2016-12-28

Participant Flow

Participants were pregnant women in their first or second pregnancy recruited during presentation at the Ndirande Antenatal Clinic (ANC) at the Ndirande Health Centre, enrolled between 22 February 2012 and 16 May 2014.

The infants born to these participants were also enrolled in the study to be assessed at birth and followed to 14 weeks. The infants are reported here as separate arms of the study, grouped by the study product given to the mother.

Participant milestones

Participant milestones
Measure	Maternal Chloroquine Prophylaxis Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Infant Chloroquine Prophylaxis Infants born to maternal participants who received chloroquine prophylaxis.	Infant Chloroquine IPT Infants born to maternal participants who received chloroquine IPT.	Infant SP IPT Infants born to maternal participants who received SP IPT.
Overall Study STARTED	300	300	300	270	274	259
Overall Study COMPLETED	232	231	223	231	230	225
Overall Study NOT COMPLETED	68	69	77	39	44	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Maternal Chloroquine Prophylaxis Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Infant Chloroquine Prophylaxis Infants born to maternal participants who received chloroquine prophylaxis.	Infant Chloroquine IPT Infants born to maternal participants who received chloroquine IPT.	Infant SP IPT Infants born to maternal participants who received SP IPT.
Overall Study Lost to Follow-up	44	42	50	23	25	21
Overall Study Death	0	1	0	7	10	8
Overall Study Adverse Event	2	1	1	0	0	0
Overall Study Protocol Violation	2	1	3	2	2	3
Overall Study Withdrawal by Subject	15	14	12	7	7	2
Overall Study Death of Subject's Infant	5	10	11	0	0	0

Baseline Characteristics

Chloroquine for Malaria in Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maternal Chloroquine Prophylaxis n=300 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=300 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=300 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Infant Chloroquine Prophylaxis n=270 Participants Infants born to maternal participants who received chloroquine prophylaxis.	Infant Chloroquine IPT n=274 Participants Infants born to maternal participants who received chloroquine IPT.	Infant SP IPT n=259 Participants Infants born to maternal participants who received SP IPT.	Total n=1703 Participants Total of all reporting groups
Age, Categorical <=18 years	99 Participants n=5 Participants	81 Participants n=7 Participants	90 Participants n=5 Participants	270 Participants n=4 Participants	274 Participants n=21 Participants	259 Participants n=8 Participants	1073 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	201 Participants n=5 Participants	219 Participants n=7 Participants	210 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	630 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	20.40 years STANDARD_DEVIATION 3.59 • n=5 Participants	20.67 years STANDARD_DEVIATION 3.24 • n=7 Participants	20.44 years STANDARD_DEVIATION 3.14 • n=5 Participants	0 years STANDARD_DEVIATION 0 • n=4 Participants	0 years STANDARD_DEVIATION 0 • n=21 Participants	0 years STANDARD_DEVIATION 0 • n=8 Participants	20.50 years STANDARD_DEVIATION 3.33 • n=8 Participants
Gender Female	300 Participants n=5 Participants	300 Participants n=7 Participants	300 Participants n=5 Participants	133 Participants n=4 Participants	143 Participants n=21 Participants	136 Participants n=8 Participants	1312 Participants n=8 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	137 Participants n=4 Participants	131 Participants n=21 Participants	123 Participants n=8 Participants	391 Participants n=8 Participants
Region of Enrollment Malawi	300 participants n=5 Participants	300 participants n=7 Participants	300 participants n=5 Participants	270 participants n=4 Participants	274 participants n=21 Participants	259 participants n=8 Participants	1703 participants n=8 Participants

PRIMARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: All participants from whom the placental histopathology slides collected at the time of delivery were reviewed are included in the analysis.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=259 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=253 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=253 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Placental Malaria Infection Based on Histology	11.58 percentage of pregnancies Interval 7.52 to 16.8	15.42 percentage of pregnancies Interval 10.67 to 21.21	15.42 percentage of pregnancies Interval 10.67 to 21.21

SECONDARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: The analysis population includes all maternal participants whose pregnancies were followed to delivery and from whom a placenta was collected and an impression smear performed.

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=259 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=254 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=253 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Placental Malaria by Placental Impression Smear	0 percentage of placentas Interval 0.0 to 1.68	0 percentage of placentas Interval 0.0 to 1.71	0.40 percentage of placentas Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: From enrollment until delivery, approximately 12-36 weeks

Population: The analysis population includes all maternal participants.

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL).

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=300 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=300 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=300 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)	18.3 percentage of maternal participants Interval 13.58 to 23.89	23.7 percentage of maternal participants Interval 18.36 to 29.64	22.0 percentage of maternal participants Interval 16.85 to 27.86

SECONDARY outcome

Timeframe: From enrollment until delivery, approximately 12-36 weeks

Population: The analysis population includes all maternal participants.

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=300 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=300 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=300 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)	0.0 percentage of maternal participants Interval 0.0 to 1.45	0.3 percentage of maternal participants Interval 0.0 to 2.11	0.3 percentage of maternal participants Interval 0.0 to 2.11

SECONDARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: The analysis population includes all participants whose pregnancies were followed to delivery.

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=272 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=273 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=263 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Stillbirth	1.10 percentage of deliveries Interval 0.17 to 3.54	0.37 percentage of deliveries Interval 0.0 to 2.31	1.90 percentage of deliveries Interval 0.52 to 4.78

SECONDARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: The analysis population includes all maternal participants.

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=300 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=300 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=300 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Miscarriage	0.33 percentage of pregnancies Interval 0.0 to 2.11	0.67 percentage of pregnancies Interval 0.06 to 2.68	1.00 percentage of pregnancies Interval 0.16 to 3.21

SECONDARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: The analysis population includes all participants whose pregnancies were followed to delivery.

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=272 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=273 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=263 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Preterm Delivery	8.46 percentage of deliveries Interval 5.08 to 13.02	9.89 percentage of deliveries Interval 6.23 to 14.69	6.84 percentage of deliveries Interval 3.8 to 11.17

SECONDARY outcome

Timeframe: For 14 weeks after delivery.

Population: The analysis population includes all enrolled infants.

Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=270 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=274 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=259 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Infant Mortality Rate to 14 Weeks of Age	2.22 percentage of infants Interval 0.7 to 5.18	3.65 percentage of infants Interval 1.58 to 7.07	3.09 percentage of infants Interval 1.18 to 6.46

SECONDARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: The analysis population includes all infants born alive with weight data collected at birth.

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=263 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=264 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=256 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)	15.59 percentage of infants Interval 10.91 to 21.28	10.98 percentage of infants Interval 7.06 to 16.05	12.11 percentage of infants Interval 7.93 to 17.44

SECONDARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: This analysis population includes all infants with weight captured at delivery and with mothers having reported gestational age at delivery.

Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=260 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=261 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=250 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Intrauterine Growth Restriction (IUGR)	16.54 percentage of participants Interval 11.7 to 22.37	18.01 percentage of participants Interval 12.98 to 23.98	20.80 percentage of participants Interval 15.32 to 27.17

SECONDARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: This analysis population includes all maternal subjects with placental slides reviewed and PCR results obtained.

Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR).

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=259 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=253 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=253 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Active Placental Malaria Infection	3.09 percentage of participants Interval 1.18 to 6.46	3.16 percentage of participants Interval 1.21 to 6.61	4.74 percentage of participants Interval 2.24 to 8.67

SECONDARY outcome

Timeframe: Enrollment to delivery (approximately 12-36 weeks)

Population: The analysis population includes all maternal participants.

Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=300 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=300 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=300 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Malaria Infection, All Species.	0.67 percentage of participants Interval 0.06 to 2.68	1.67 percentage of participants Interval 0.45 to 4.2	3.00 percentage of participants Interval 1.22 to 6.03

SECONDARY outcome

Timeframe: Enrollment to delivery (approximately 12-36 weeks)

Population: The analysis population includes all maternal participants.

Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=300 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=300 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=300 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Clinical Malaria, All Species	0.67 percentage of participants Interval 0.53 to 4.89	1.33 percentage of participants Interval 0.97 to 6.09	3.00 percentage of participants Interval 0.07 to 3.2

SECONDARY outcome

Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Population: The analysis population includes all maternal participants with cord blood smears and cord PCR results obtained.

Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample.

Outcome measures

Outcome measures
Measure	Maternal Chloroquine Prophylaxis n=257 Participants Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=252 Participants Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=251 Participants Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Incidence of Infection in the Fetal Circulation	1.95 percentage of participants Interval 0.53 to 4.89	2.78 percentage of participants Interval 0.97 to 6.09	0.80 percentage of participants Interval 0.07 to 3.2

Adverse Events

Maternal Chloroquine Prophylaxis

Serious events: 23 serious events

Other events: 255 other events

Deaths: 0 deaths

Maternal Chloroquine IPT

Serious events: 29 serious events

Other events: 251 other events

Deaths: 0 deaths

Maternal SP IPT

Serious events: 26 serious events

Other events: 234 other events

Deaths: 0 deaths

Infant Chloroquine Prophylaxis

Serious events: 46 serious events

Other events: 195 other events

Deaths: 0 deaths

Infant Chloroquine IPT

Serious events: 65 serious events

Other events: 186 other events

Deaths: 0 deaths

Infant SP IPT

Serious events: 43 serious events

Other events: 171 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Maternal Chloroquine Prophylaxis n=300 participants at risk Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=300 participants at risk Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=300 participants at risk Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Infant Chloroquine Prophylaxis n=270 participants at risk Infants born to maternal participants who received chloroquine prophylaxis.	Infant Chloroquine IPT n=274 participants at risk Infants born to maternal participants who received chloroquine IPT.	Infant SP IPT n=259 participants at risk Infants born to maternal participants who received SP IPT.
Blood and lymphatic system disorders Anaemia	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Blood and lymphatic system disorders Anaemia of pregnancy	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Gastrointestinal disorders Constipation	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Bartholin's abscess	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Dysentery	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Gastroenteritis	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Incision site infection	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Malaria	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Peritonitis	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Pneumonia	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.74% 2/270 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.1% 3/274 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Postoperative wound infection	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Postpartum sepsis	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Urinary tract infection	1.0% 3/300 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.3% 4/300 • Number of events 4 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Wound infection	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Eclampsia	1.0% 3/300 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.0% 3/300 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Foetal death	1.0% 3/300 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.3% 4/300 • Number of events 4 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.33% 1/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Premature delivery	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Premature labour	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.0% 6/300 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.7% 5/300 • Number of events 5 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Prolonged rupture of membranes	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Uterine contractions during pregnancy	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Psychiatric disorders Brief psychotic disorder, with postpartum onset	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Psychiatric disorders Psychotic disorder	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Cardiac disorders Cardio-respiratory arrest	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Congenital, familial and genetic disorders Accessory auricle	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Congenital, familial and genetic disorders Heart disease congenital	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Congenital, familial and genetic disorders Laryngomalacia	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.39% 1/259 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Congenital, familial and genetic disorders Polydactyly	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.2% 6/270 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.3% 9/274 • Number of events 9 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.3% 6/259 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Congenital, familial and genetic disorders Talipes	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Congenital, familial and genetic disorders Umbilical cord haemorrhage	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
General disorders Death neonatal	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
General disorders Pyrexia	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.77% 2/259 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
General disorders Sudden infant death syndrome	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.39% 1/259 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Abscess	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Bronchiolitis	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.9% 5/270 • Number of events 5 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.5% 4/274 • Number of events 4 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.39% 1/259 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Group B streptococcus neonatal sepsis	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.74% 2/270 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Sepsis	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Sepsis neonatal	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.2% 6/270 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.6% 10/274 • Number of events 10 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.6% 12/259 • Number of events 12 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Staphylococcal sepsis	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Upper respiratory tract infection	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.74% 2/270 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Metabolism and nutrition disorders Failure to thrive	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.74% 2/270 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Metabolism and nutrition disorders Feeding disorder neonatal	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.39% 1/259 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Metabolism and nutrition disorders Marasmus	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.77% 2/259 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Nervous system disorders Myoclonus	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.39% 1/259 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.9% 5/270 • Number of events 5 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.3% 9/274 • Number of events 9 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.77% 2/259 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.2% 6/270 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.1% 8/259 • Number of events 8 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Respiratory, thoracic and mediastinal disorders Neonatal aspiration	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.39% 1/259 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.1% 3/274 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.2% 3/259 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.39% 1/259 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.2% 3/259 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.2% 6/274 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.2% 3/259 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Skin and subcutaneous tissue disorders Melanosis	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Surgical and medical procedures Vacuum extractor delivery	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.37% 1/270 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).

Other adverse events

Other adverse events
Measure	Maternal Chloroquine Prophylaxis n=300 participants at risk Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.	Maternal Chloroquine IPT n=300 participants at risk Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Maternal SP IPT n=300 participants at risk Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.	Infant Chloroquine Prophylaxis n=270 participants at risk Infants born to maternal participants who received chloroquine prophylaxis.	Infant Chloroquine IPT n=274 participants at risk Infants born to maternal participants who received chloroquine IPT.	Infant SP IPT n=259 participants at risk Infants born to maternal participants who received SP IPT.
Blood and lymphatic system disorders Anaemia	4.0% 12/300 • Number of events 14 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.7% 20/300 • Number of events 21 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.7% 17/300 • Number of events 17 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Cardiac disorders Palpitations	5.3% 16/300 • Number of events 16 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.3% 19/300 • Number of events 21 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.7% 8/300 • Number of events 8 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Gastrointestinal disorders Abdominal pain	26.0% 78/300 • Number of events 92 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	24.3% 73/300 • Number of events 90 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	20.7% 62/300 • Number of events 77 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.5% 4/270 • Number of events 4 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.73% 2/274 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.77% 2/259 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Gastrointestinal disorders Diarrhoea	12.0% 36/300 • Number of events 39 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	9.3% 28/300 • Number of events 29 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.3% 16/300 • Number of events 17 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.3% 9/270 • Number of events 9 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.2% 6/274 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.9% 5/259 • Number of events 5 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Gastrointestinal disorders Nausea	1.0% 3/300 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.7% 17/300 • Number of events 20 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Gastrointestinal disorders Vomiting	10.7% 32/300 • Number of events 37 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	21.0% 63/300 • Number of events 75 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.3% 16/300 • Number of events 17 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.1% 3/270 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.2% 6/274 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.5% 4/259 • Number of events 4 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
General disorders Pain	5.3% 16/300 • Number of events 18 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	8.7% 26/300 • Number of events 30 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	7.0% 21/300 • Number of events 21 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Gastroenteritis	6.7% 20/300 • Number of events 23 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.3% 10/300 • Number of events 12 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.0% 18/300 • Number of events 19 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.3% 9/270 • Number of events 10 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.3% 9/274 • Number of events 9 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.2% 3/259 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Tonsillitis	7.7% 23/300 • Number of events 25 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.0% 12/300 • Number of events 13 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.0% 12/300 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Upper respiratory tract infection	30.0% 90/300 • Number of events 113 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	21.7% 65/300 • Number of events 70 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	24.3% 73/300 • Number of events 82 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	50.4% 136/270 • Number of events 172 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	45.3% 124/274 • Number of events 154 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	45.6% 118/259 • Number of events 152 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Urinary tract infection	8.3% 25/300 • Number of events 29 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	9.0% 27/300 • Number of events 28 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	9.0% 27/300 • Number of events 28 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Vulvovaginal candidiasis	3.7% 11/300 • Number of events 13 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.7% 17/300 • Number of events 18 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.3% 13/300 • Number of events 14 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Investigations Blood pressure increased	4.0% 12/300 • Number of events 12 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.0% 12/300 • Number of events 12 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.7% 20/300 • Number of events 20 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Musculoskeletal and connective tissue disorders Back pain	7.0% 21/300 • Number of events 25 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.3% 19/300 • Number of events 21 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.3% 16/300 • Number of events 16 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	26.3% 79/300 • Number of events 88 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	25.0% 75/300 • Number of events 95 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	18.7% 56/300 • Number of events 70 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.36% 1/274 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Nervous system disorders Dizziness	5.3% 16/300 • Number of events 16 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	20.7% 62/300 • Number of events 75 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.0% 12/300 • Number of events 12 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Nervous system disorders Headache	29.3% 88/300 • Number of events 113 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	25.3% 76/300 • Number of events 96 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	25.3% 76/300 • Number of events 89 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Gestational hypertension	8.0% 24/300 • Number of events 24 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	9.3% 28/300 • Number of events 28 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	8.7% 26/300 • Number of events 27 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Pregnancy, puerperium and perinatal conditions Prolonged labour	6.7% 20/300 • Number of events 20 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	8.3% 25/300 • Number of events 25 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	7.3% 22/300 • Number of events 22 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Renal and urinary disorders Proteinuria	3.7% 11/300 • Number of events 11 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	8.0% 24/300 • Number of events 24 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.0% 15/300 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Vascular disorders Hypotension	4.0% 12/300 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.7% 20/300 • Number of events 24 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.0% 12/300 • Number of events 16 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/270 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/274 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/259 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Eye disorders Conjunctivitis	1.0% 3/300 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.3% 7/300 • Number of events 7 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	8.1% 22/270 • Number of events 22 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	9.9% 27/274 • Number of events 28 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.6% 17/259 • Number of events 17 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
General disorders Pyrexia	2.3% 7/300 • Number of events 8 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.3% 13/300 • Number of events 14 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.0% 6/300 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.7% 18/270 • Number of events 19 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.5% 15/274 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.6% 12/259 • Number of events 12 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Bronchiolitis	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.7% 10/270 • Number of events 10 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.6% 7/274 • Number of events 7 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.6% 17/259 • Number of events 18 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Impetigo	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.5% 4/270 • Number of events 4 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.1% 3/274 • Number of events 3 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.4% 14/259 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Nasopharyngitis	5.0% 15/300 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.3% 7/300 • Number of events 7 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.0% 15/300 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.7% 18/270 • Number of events 19 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.9% 19/274 • Number of events 19 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.9% 18/259 • Number of events 18 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Pneumonia	4.0% 12/300 • Number of events 13 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.7% 5/300 • Number of events 5 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.3% 4/300 • Number of events 4 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	3.0% 8/270 • Number of events 8 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.5% 15/274 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.2% 11/259 • Number of events 11 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Respiratory tract infection	4.3% 13/300 • Number of events 13 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.0% 6/300 • Number of events 6 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	1.3% 4/300 • Number of events 4 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	7.0% 19/270 • Number of events 19 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	10.6% 29/274 • Number of events 31 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	6.6% 17/259 • Number of events 18 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Rhinitis	4.0% 12/300 • Number of events 12 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	2.7% 8/300 • Number of events 8 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.7% 14/300 • Number of events 16 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.6% 15/270 • Number of events 16 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.8% 16/274 • Number of events 16 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	4.6% 12/259 • Number of events 13 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Infections and infestations Skin bacterial infection	0.67% 2/300 • Number of events 2 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.00% 0/300 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	0.33% 1/300 • Number of events 1 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	8.1% 22/270 • Number of events 25 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	5.5% 15/274 • Number of events 15 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).	7.3% 19/259 • Number of events 19 • Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).

Additional Information

Miriam K. Laufer, MD, MPH

University of Maryland School of Medicine

Phone: 410-706-5333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60