Trial Outcomes & Findings for Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa (NCT NCT01103063)

Last Updated: 2015-06-16

Results Overview

Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (\<2,500 g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2891 participants

Primary outcome timeframe

Approximately 40 weeks of gestational age

Results posted on

2015-06-16

Participant Flow

This Phase 3, open label, randomized, parallel group study screened a total of 3259 participants in 6 sites. A total of 2891 were treated either with azithromycin+chloroquine or sulfadoxine+pyrimethamine.

Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age were to be enrolled in this study. Approximately half of the participants were to be primigravidae and secundigravidae pregnant women since they had a higher risk for suboptimal pregnancy outcomes due to malaria.

Participant milestones

Participant milestones
Measure	Azithromycin + Chloroquine The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Overall Study STARTED	1446	1445
Overall Study COMPLETED	969	1024
Overall Study NOT COMPLETED	477	421

Reasons for withdrawal

Reasons for withdrawal
Measure	Azithromycin + Chloroquine The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Overall Study Adverse Event	3	1
Overall Study Lost to Follow-up	68	51
Overall Study Withdrawal by Subject	60	15
Overall Study Other	16	11
Overall Study Protocol Violation	1	0
Overall Study Study terminated by Sponsor	326	342
Overall Study Death	3	1

Baseline Characteristics

Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithromycin + Chloroquine n=1446 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.	Total n=2891 Participants Total of all reporting groups
Age, Continuous	23.3 Years STANDARD_DEVIATION 4.5 • n=5 Participants	23.3 Years STANDARD_DEVIATION 4.6 • n=7 Participants	23.3 Years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	1446 Participants n=5 Participants	1445 Participants n=7 Participants	2891 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 40 weeks of gestational age

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population	26.16 Percentage of participants Interval 23.89 to 28.43	23.67 Percentage of participants Interval 21.48 to 25.86

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

Population: Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care.

Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (\<2,500g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1089 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1176 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population	10.38 Percentage of Participants Interval 8.57 to 12.19	10.12 Percentage of Participants Interval 8.4 to 11.84

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

LBW was defined as live birth weight \<2500 g (up to and including 2499 g).

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1140 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1190 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Neonates With LBW (<2500 g) in ITT Population	5.01 Percentage of neonates Interval 3.74 to 6.28	5.72 Percentage of neonates Interval 4.4 to 7.04

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

LBW was defined as live birth weight \<2500 g (up to and including 2499 g).

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1041 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1134 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population	4.72 Percentage of neonates Interval 3.43 to 6.01	5.21 Percentage of neonates Interval 3.92 to 6.5

SECONDARY outcome

Timeframe: At 36-38 weeks of gestation.

Severe maternal anemia was defined as Hb \<8 g/dL.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1222 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1299 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation	1.80 Percentage of participants Interval 1.05 to 2.55	2.00 Percentage of participants Interval 1.24 to 2.76

SECONDARY outcome

Timeframe: At 36-38 weeks of gestation.

Anemia was defined as Hb \<11 g/dL.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1222 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1299 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation	50.57 Percentage of Participants Interval 47.77 to 53.37	49.11 Percentage of Participants Interval 46.39 to 51.83

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1019 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1076 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Placental Parasitemia at Delivery	5.30 Percentage of participants Interval 3.92 to 6.67	5.67 Percentage of participants Interval 4.29 to 7.05

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

Participants positive for placental malaria at delivery were evaluated based on placental histology.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1040 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1100 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Placental Malaria at Delivery Based on Histology	4.81 Percentage of participants Interval 3.51 to 6.11	5.73 Percentage of participants Interval 4.36 to 7.1

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age .

Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Sexually Transmitted Infection (STI) Episodes Per Participant	0.14 Number of episodes Interval 0.11 to 0.16	0.19 Number of episodes Interval 0.17 to 0.21

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age.

Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight \<2,500g), premature birth (\<37 weeks), abortion (≤28 weeks), still birth (\>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation	28.51 Percentage of participants Interval 26.18 to 30.84	26.51 Percentage of participants Interval 24.23 to 28.79

SECONDARY outcome

Timeframe: Baseline, at 36-38 weeks of gestation.

Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1221 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1298 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.	0.13 g/dL Interval 0.05 to 0.21	0.27 g/dL Interval 0.19 to 0.34

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age.

Neonates with congenital abnormalities at birth were noted.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1140 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1190 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Neonates With Congenital Abnormalities at Birth	2.19 Percentage of neonates Interval 1.34 to 3.04	2.44 Percentage of neonates Interval 1.56 to 3.31

SECONDARY outcome

Timeframe: Day 28 after delivery.

Percentage of perinatal or neonatal deaths were noted.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1140 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1190 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Perinatal or Neonatal Deaths	2.19 Percentage of neonates Interval 1.34 to 3.04	1.85 Percentage of neonates Interval 1.08 to 2.62

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age.

Birth weight of live borne neonates were calculated in grams.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1138 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1188 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Birth Weight of Live Borne Neonate	3148.3 grams Interval 3120.0 to 3176.0	3146.2 grams Interval 3119.0 to 3174.0

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever \>37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery	0.06 Number of episodes Interval 0.04 to 0.08	0.13 Number of episodes Interval 0.11 to 0.15

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery	5.74 Percentage of participants Interval 4.54 to 6.94	10.52 Percentage of participants Interval 8.94 to 12.1

SECONDARY outcome

Timeframe: At 36-38 weeks of gestation

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at 36-38 weeks of gestation.

This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1069 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1142 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation	2.71 Percentage of participants Interval 1.74 to 3.68	4.38 Percentage of participants Interval 3.19 to 5.57

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1025 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1086 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Peripheral Parasitemia at Delivery	6.05 Percentage of participants Interval 4.59 to 7.51	7.46 Percentage of participants Interval 5.9 to 9.02

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1015 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1072 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Cord Blood Parasitemia at Delivery	0.49 Percentage of participants Interval 0.06 to 0.92	0.75 Percentage of participants Interval 0.23 to 1.27

SECONDARY outcome

Timeframe: Upto 36-38 weeks of gestation

Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation	12.32 Percentage of participants Interval 10.63 to 14.01	16.47 Percentage of participants Interval 14.56 to 18.38

SECONDARY outcome

Timeframe: At 36-38 weeks of gestation

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with lab test results at 36-38 weeks of gestation.

Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=746 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=794 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation	1.47 Percentage of participants Interval 0.61 to 2.33	0.63 Percentage of participants Interval 0.08 to 1.18

SECONDARY outcome

Timeframe: At 36-38 weeks of gestation

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.

Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=746 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=794 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation	0.40 Percentage of participants Interval 0.0 to 0.85	1.64 Percentage of participants Interval 0.76 to 2.52

SECONDARY outcome

Timeframe: At 36-38 weeks of gestation

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.

Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=751 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=797 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation	0.93 Percentage of participants Interval 0.24 to 1.62	2.01 Percentage of participants Interval 1.04 to 2.98

SECONDARY outcome

Timeframe: At 36-38 weeks of gestation

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.

Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1068 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1143 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation	8.24 Percentage of participants Interval 6.59 to 9.89	10.67 Percentage of participants Interval 8.88 to 12.46

SECONDARY outcome

Timeframe: At 36-38 weeks of gestation

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.

Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=746 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=794 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.	8.58 Percentage of participants Interval 6.57 to 10.59	11.84 Percentage of participants Interval 9.59 to 14.09

SECONDARY outcome

Timeframe: Approximately 40 weeks of gestational age

Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1140 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1190 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Neonates With Ophthalmia Neonatorum at Birth Period	0.35 Percentage of neonates Interval 0.01 to 0.69	0.17 Percentage of neonates Interval 0.0 to 0.4

SECONDARY outcome

Timeframe: Up to approximately 40 weeks of gestational age

Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery	0.48 Percentage of participants Interval 0.13 to 0.84	1.25 Percentage of participants Interval 0.67 to 1.82

SECONDARY outcome

Timeframe: From Week 20 to approximately 40 weeks of gestational age

Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1440 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1443 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Percentage of Participants With Pre-eclampsia From Week 20 to Delivery	0.63 Percentage of participants Interval 0.22 to 1.03	1.04 Percentage of participants Interval 0.51 to 1.55

SECONDARY outcome

Timeframe: Visits 6 and 7

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.

This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae Visit 6 (N = 8 and 17 respectively)	0 Percentage of participants	11.76 Percentage of participants
Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae Visit 7 (N = 16 and 11 respectively)	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Visits 6 and 7

Population: ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.

This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.

Outcome measures

Outcome measures
Measure	Azithromycin + Chloroquine n=1445 Participants The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Sulfadoxine + Pyrimethamine n=1445 Participants The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae Visit 6 (N = 8 and 17 respectively)	0 Percentage of participants	0 Percentage of participants
Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae Visit 7 (N = 16 and 11 respectively)	0 Percentage of participants	0 Percentage of participants

Adverse Events

Mother (Azithromycin + Chloroquine)

Serious events: 65 serious events

Other events: 1177 other events

Deaths: 0 deaths

Mother (Sulfadoxine + Pyrimethamine)

Serious events: 42 serious events

Other events: 888 other events

Deaths: 0 deaths

Neonate (Azithromycin + Chloroquine)

Serious events: 101 serious events

Other events: 301 other events

Deaths: 0 deaths

Neonate (Sulfadoxine + Pyrimethamine)

Serious events: 104 serious events

Other events: 326 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Mother (Azithromycin + Chloroquine) n=1446 participants at risk The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Mother (Sulfadoxine + Pyrimethamine) n=1445 participants at risk The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.	Neonate (Azithromycin + Chloroquine) n=1149 participants at risk Live births of participants who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Neonate (Sulfadoxine + Pyrimethamine) n=1196 participants at risk Live births of participants who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Blood and lymphatic system disorders Anaemia	0.07% 1/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.26% 3/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Blood and lymphatic system disorders Haemorrhagic disease of newborn	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Cardiac disorders Tricuspid valve disease	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Anal atresia	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Cerebellar hypoplasia	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Congenital hand malformation	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Congenital malaria	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.26% 3/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Congenital umbilical hernia	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Cystic lymphangioma	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Dysmorphism	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Exomphalos	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Heart disease congenital	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Hypospadias	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Microgenia	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Polydactyly	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.4% 16/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.8% 21/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Congenital, familial and genetic disorders Talipes	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Diarrhoea	0.07% 1/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Enterocolitis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Gastritis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.07% 1/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Necrotising colitis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Rectourethral fistula	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Umbilical hernia	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.25% 3/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Vomiting	0.21% 3/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
General disorders Asthenia	0.07% 1/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
General disorders Death neonatal	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
General disorders Pyrexia	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Hepatobiliary disorders Hepatitis cholestatic	0.07% 1/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Hepatobiliary disorders Jaundice	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Arthritis bacterial	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Bartholin's abscess	0.07% 1/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Bronchiolitis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Bronchopneumonia	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Cellulitis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.07% 1/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Encephalitis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Gastroenteritis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Herpes zoster	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Malaria	0.14% 2/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.62% 9/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.17% 2/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.25% 3/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Meningitis	0.07% 1/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.09% 1/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.08% 1/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Neonatal infection	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.44% 5/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.33% 4/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.

Other adverse events
Measure	Mother (Azithromycin + Chloroquine) n=1446 participants at risk The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Mother (Sulfadoxine + Pyrimethamine) n=1445 participants at risk The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.	Neonate (Azithromycin + Chloroquine) n=1149 participants at risk Live births of participants who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.	Neonate (Sulfadoxine + Pyrimethamine) n=1196 participants at risk Live births of participants who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Blood and lymphatic system disorders Anaemia	14.2% 205/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	13.3% 192/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.8% 21/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.2% 14/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Eye disorders Vision blurred	10.0% 145/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.07% 1/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Abdominal discomfort	8.5% 123/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.5% 50/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Abdominal pain	8.3% 120/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	2.5% 36/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Abdominal pain lower	3.5% 50/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.1% 45/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Diarrhoea	14.2% 205/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.97% 14/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Dyspepsia	0.55% 8/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.0% 15/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Gastritis	1.6% 23/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.48% 7/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Nausea	14.9% 216/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	4.0% 58/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Gastrointestinal disorders Vomiting	45.0% 650/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	6.6% 96/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
General disorders Asthenia	16.5% 239/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	2.8% 40/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
General disorders Fatigue	5.6% 81/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.5% 22/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
General disorders Pyrexia	0.69% 10/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.8% 26/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.5% 40/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	2.3% 28/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Conjunctivitis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.3% 15/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.84% 10/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Gastroenteritis	3.0% 44/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.5% 21/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	4.2% 48/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.1% 37/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Infection parasitic	0.97% 14/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.2% 18/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Malaria	3.4% 49/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	8.4% 121/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.2% 37/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.1% 37/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Pneumonia	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.0% 34/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	2.1% 25/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Sepsis	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.6% 18/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.75% 9/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Sepsis neonatal	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.8% 21/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.8% 21/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Trichomoniasis	4.0% 58/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.8% 55/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Upper respiratory tract infection	8.8% 127/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	10.6% 153/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	10.9% 125/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	9.7% 116/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Urinary tract infection	7.3% 105/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	8.0% 115/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Infections and infestations Vulvovaginal candidiasis	5.2% 75/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	4.2% 60/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Injury, poisoning and procedural complications Perineal injury	1.3% 19/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.4% 20/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Investigations White blood cells urine positive	10.3% 149/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	11.2% 162/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Metabolism and nutrition disorders Decreased appetite	3.0% 44/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.76% 11/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Musculoskeletal and connective tissue disorders Back pain	2.3% 33/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	2.0% 29/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Nervous system disorders Dizziness	31.8% 460/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	5.8% 84/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Nervous system disorders Headache	20.7% 300/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	15.2% 219/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Nervous system disorders Somnolence	2.6% 38/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	2.5% 29/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	3.3% 39/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	2.4% 28/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	2.3% 28/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Respiratory, thoracic and mediastinal disorders Cough	1.0% 15/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.69% 10/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Skin and subcutaneous tissue disorders Pruritus	3.2% 46/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	1.6% 23/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Skin and subcutaneous tissue disorders Pruritus generalised	1.5% 22/1446 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.55% 8/1445 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1149 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.	0.00% 0/1196 • Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.