Trial Outcomes & Findings for Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy (NCT NCT03965923)
NCT ID: NCT03965923
Last Updated: 2025-08-12
Results Overview
All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Composite safety endpoint AEs were AEs that were either categorized as serious adverse events (SAEs) or were Grade 3 or higher. This measure is the number of participants with at least one composite AE.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1104 participants
Primary outcome timeframe
Measured through participant's last study visit. For mothers, this occurred at approximately Week 12 to 36, depending on participant's cohort, and for infants at approximately Week 52.
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
49
|
106
|
51
|
202
|
49
|
99
|
48
|
103
|
51
|
197
|
48
|
|
Overall Study
COMPLETED
|
98
|
46
|
102
|
49
|
198
|
48
|
93
|
43
|
95
|
49
|
189
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
4
|
2
|
4
|
1
|
6
|
5
|
8
|
2
|
8
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
3
|
1
|
2
|
0
|
4
|
3
|
4
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
0
|
2
|
1
|
2
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
4
|
0
|
|
Overall Study
Other reason
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Infants were enrolled on their date of birth, so their age in years at enrollment was 0 years by definition and is omitted. Their gestational age at birth is reported as a separate baseline measure.
Baseline characteristics by cohort
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=101 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=49 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=106 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=51 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=202 Participants
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
n=49 Participants
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=99 Participants
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
n=48 Participants
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=103 Participants
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
n=51 Participants
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=197 Participants
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
n=48 Participants
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Total
n=1104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.4 years
STANDARD_DEVIATION 5.4 • n=101 Participants • Infants were enrolled on their date of birth, so their age in years at enrollment was 0 years by definition and is omitted. Their gestational age at birth is reported as a separate baseline measure.
|
25.1 years
STANDARD_DEVIATION 5.4 • n=49 Participants • Infants were enrolled on their date of birth, so their age in years at enrollment was 0 years by definition and is omitted. Their gestational age at birth is reported as a separate baseline measure.
|
26.2 years
STANDARD_DEVIATION 5.5 • n=106 Participants • Infants were enrolled on their date of birth, so their age in years at enrollment was 0 years by definition and is omitted. Their gestational age at birth is reported as a separate baseline measure.
|
26.7 years
STANDARD_DEVIATION 6.2 • n=51 Participants • Infants were enrolled on their date of birth, so their age in years at enrollment was 0 years by definition and is omitted. Their gestational age at birth is reported as a separate baseline measure.
|
25.7 years
STANDARD_DEVIATION 5.4 • n=202 Participants • Infants were enrolled on their date of birth, so their age in years at enrollment was 0 years by definition and is omitted. Their gestational age at birth is reported as a separate baseline measure.
|
24.0 years
STANDARD_DEVIATION 5.1 • n=49 Participants • Infants were enrolled on their date of birth, so their age in years at enrollment was 0 years by definition and is omitted. Their gestational age at birth is reported as a separate baseline measure.
|
40.1 weeks
STANDARD_DEVIATION 1.6 • n=99 Participants • Infants were enrolled on their date of birth, so their age at enrollment was 0 years by definition. In place of age at enrollment, gestational age at birth is reported. This measure is only collected for infants.
|
39.6 weeks
STANDARD_DEVIATION 1.6 • n=48 Participants • Infants were enrolled on their date of birth, so their age at enrollment was 0 years by definition. In place of age at enrollment, gestational age at birth is reported. This measure is only collected for infants.
|
39.6 weeks
STANDARD_DEVIATION 1.8 • n=103 Participants • Infants were enrolled on their date of birth, so their age at enrollment was 0 years by definition. In place of age at enrollment, gestational age at birth is reported. This measure is only collected for infants.
|
39.4 weeks
STANDARD_DEVIATION 1.7 • n=51 Participants • Infants were enrolled on their date of birth, so their age at enrollment was 0 years by definition. In place of age at enrollment, gestational age at birth is reported. This measure is only collected for infants.
|
39.8 weeks
STANDARD_DEVIATION 1.6 • n=197 Participants • Infants were enrolled on their date of birth, so their age at enrollment was 0 years by definition. In place of age at enrollment, gestational age at birth is reported. This measure is only collected for infants.
|
39.4 weeks
STANDARD_DEVIATION 1.5 • n=48 Participants • Infants were enrolled on their date of birth, so their age at enrollment was 0 years by definition. In place of age at enrollment, gestational age at birth is reported. This measure is only collected for infants.
|
39.7 weeks
STANDARD_DEVIATION 1.7 • n=546 Participants • Infants were enrolled on their date of birth, so their age at enrollment was 0 years by definition. In place of age at enrollment, gestational age at birth is reported. This measure is only collected for infants.
|
|
Sex: Female, Male
Female
|
101 Participants
n=101 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
49 Participants
n=49 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
106 Participants
n=106 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
51 Participants
n=51 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
202 Participants
n=202 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
49 Participants
n=49 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
48 Participants
n=99 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
24 Participants
n=48 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
62 Participants
n=103 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
24 Participants
n=50 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
104 Participants
n=197 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
25 Participants
n=48 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
845 Participants
n=1103 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
|
Sex: Female, Male
Male
|
0 Participants
n=101 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
0 Participants
n=49 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
0 Participants
n=106 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
0 Participants
n=51 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
0 Participants
n=202 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
0 Participants
n=49 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
51 Participants
n=99 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
24 Participants
n=48 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
41 Participants
n=103 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
26 Participants
n=50 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
93 Participants
n=197 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
23 Participants
n=48 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
258 Participants
n=1103 Participants • The infant analysis population is enrolled infants whose sex at birth was available.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=101 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=197 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=1104 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=101 Participants
|
49 Participants
n=49 Participants
|
106 Participants
n=106 Participants
|
51 Participants
n=51 Participants
|
202 Participants
n=202 Participants
|
49 Participants
n=49 Participants
|
99 Participants
n=99 Participants
|
48 Participants
n=48 Participants
|
103 Participants
n=103 Participants
|
51 Participants
n=51 Participants
|
197 Participants
n=197 Participants
|
48 Participants
n=48 Participants
|
1104 Participants
n=1104 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=101 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=197 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=1104 Participants
|
|
Region of Enrollment
Malawi
|
18 participants
n=101 Participants
|
9 participants
n=49 Participants
|
26 participants
n=106 Participants
|
14 participants
n=51 Participants
|
53 participants
n=202 Participants
|
13 participants
n=49 Participants
|
18 participants
n=99 Participants
|
9 participants
n=48 Participants
|
26 participants
n=103 Participants
|
13 participants
n=51 Participants
|
53 participants
n=197 Participants
|
13 participants
n=48 Participants
|
265 participants
n=1104 Participants
|
|
Region of Enrollment
South Africa
|
28 participants
n=101 Participants
|
14 participants
n=49 Participants
|
20 participants
n=106 Participants
|
8 participants
n=51 Participants
|
35 participants
n=202 Participants
|
9 participants
n=49 Participants
|
26 participants
n=99 Participants
|
14 participants
n=48 Participants
|
18 participants
n=103 Participants
|
8 participants
n=51 Participants
|
32 participants
n=197 Participants
|
8 participants
n=48 Participants
|
220 participants
n=1104 Participants
|
|
Region of Enrollment
Uganda
|
30 participants
n=101 Participants
|
14 participants
n=49 Participants
|
28 participants
n=106 Participants
|
14 participants
n=51 Participants
|
55 participants
n=202 Participants
|
13 participants
n=49 Participants
|
30 participants
n=99 Participants
|
14 participants
n=48 Participants
|
27 participants
n=103 Participants
|
15 participants
n=51 Participants
|
54 participants
n=197 Participants
|
13 participants
n=48 Participants
|
307 participants
n=1104 Participants
|
|
Region of Enrollment
Zimbabwe
|
25 participants
n=101 Participants
|
12 participants
n=49 Participants
|
32 participants
n=106 Participants
|
15 participants
n=51 Participants
|
59 participants
n=202 Participants
|
14 participants
n=49 Participants
|
25 participants
n=99 Participants
|
11 participants
n=48 Participants
|
32 participants
n=103 Participants
|
15 participants
n=51 Participants
|
58 participants
n=197 Participants
|
14 participants
n=48 Participants
|
312 participants
n=1104 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last study visit. For mothers, this occurred at approximately Week 12 to 36, depending on participant's cohort, and for infants at approximately Week 52.Population: All mothers who were randomized and enrolled are included. All enrolled infants are included.
All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Composite safety endpoint AEs were AEs that were either categorized as serious adverse events (SAEs) or were Grade 3 or higher. This measure is the number of participants with at least one composite AE.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=101 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=49 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=106 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=51 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=202 Participants
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
n=49 Participants
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=99 Participants
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
n=48 Participants
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=103 Participants
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
n=51 Participants
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=197 Participants
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
n=48 Participants
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Composite Safety Endpoint Adverse Event (AE)
|
2 Participants
|
6 Participants
|
16 Participants
|
5 Participants
|
24 Participants
|
4 Participants
|
23 Participants
|
15 Participants
|
30 Participants
|
10 Participants
|
48 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohortPopulation: The analysis population is all randomized and enrolled participants with an obtainable pregnancy outcome. The number of units analyzed is the number of pregnancy outcomes, due to the potential for participants to have non-singleton pregnancies.
Frequency of different types of pregnancy outcomes among mothers.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=99 Obtainable pregnancy outcomes
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=49 Obtainable pregnancy outcomes
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=104 Obtainable pregnancy outcomes
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=51 Obtainable pregnancy outcomes
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=199 Obtainable pregnancy outcomes
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
n=48 Obtainable pregnancy outcomes
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pregnancy Outcomes
Full term live birth (>= 37 0/7 weeks)
|
98 Obtainable pregnancy outcomes
|
45 Obtainable pregnancy outcomes
|
97 Obtainable pregnancy outcomes
|
46 Obtainable pregnancy outcomes
|
188 Obtainable pregnancy outcomes
|
45 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Outcomes
Premature live birth (<37 0/7 weeks)
|
1 Obtainable pregnancy outcomes
|
3 Obtainable pregnancy outcomes
|
6 Obtainable pregnancy outcomes
|
5 Obtainable pregnancy outcomes
|
8 Obtainable pregnancy outcomes
|
3 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Outcomes
Stillbirth/intrauterine fetal demise (>= 20 0/7 weeks)
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
2 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Outcomes
Spontaneous abortion (<20 0/7 weeks)
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohortPopulation: The analysis population is all randomized and enrolled participants with an obtainable pregnancy outcome. The number of units analyzed is the number of pregnancy outcomes, due to the potential for participants to have non-singleton pregnancies.
Frequency of different types of pregnancy complications among mothers. The categories of pregnancy complications were pre-defined on the case report form, and after the completion of Cohort 1 follow-up there were some changes made to the pregnancy complication categories. In Cohort 1 the category "peripartum hemorrhage" was collected, but in Cohort 2 and 3 this category was removed from the list of pre-defined complications. Two other categories, "antepartum hemorrhage" and "intrapartum hemorrhage", were added to the list for Cohort 2 and Cohort 3. As a result, participants in Cohort 1 were not evaluated for antepartum or intrapartum hemorrhage, while participants in Cohorts 2 and 3 were not evaluated for peripartum hemorrhage. All other complications were collected for all three cohorts, and participants in all three cohorts were evaluated for each complication.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=99 Obtainable pregnancy outcomes
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=49 Obtainable pregnancy outcomes
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=104 Obtainable pregnancy outcomes
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=51 Obtainable pregnancy outcomes
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=199 Obtainable pregnancy outcomes
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
n=48 Obtainable pregnancy outcomes
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Hypertensive disorders of pregnancy · Yes
|
3 Obtainable pregnancy outcomes
|
4 Obtainable pregnancy outcomes
|
9 Obtainable pregnancy outcomes
|
7 Obtainable pregnancy outcomes
|
20 Obtainable pregnancy outcomes
|
7 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Hypertensive disorders of pregnancy · No
|
96 Obtainable pregnancy outcomes
|
45 Obtainable pregnancy outcomes
|
95 Obtainable pregnancy outcomes
|
44 Obtainable pregnancy outcomes
|
179 Obtainable pregnancy outcomes
|
41 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Chronic hypertensive disorder · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Chronic hypertensive disorder · No
|
99 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
104 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
198 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Gestational hypertensive disorder · Yes
|
3 Obtainable pregnancy outcomes
|
2 Obtainable pregnancy outcomes
|
5 Obtainable pregnancy outcomes
|
7 Obtainable pregnancy outcomes
|
16 Obtainable pregnancy outcomes
|
6 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Gestational hypertensive disorder · No
|
96 Obtainable pregnancy outcomes
|
47 Obtainable pregnancy outcomes
|
99 Obtainable pregnancy outcomes
|
44 Obtainable pregnancy outcomes
|
183 Obtainable pregnancy outcomes
|
42 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Pre-eclampsia without severe features · Yes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
3 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Pre-eclampsia without severe features · No
|
99 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
103 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
196 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Pre-eclampsia with severe features · Yes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
2 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Pre-eclampsia with severe features · No
|
99 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
102 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
198 Obtainable pregnancy outcomes
|
47 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Eclampsia · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Eclampsia · No
|
99 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
104 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
199 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Unspecified hypertensive disorder · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Unspecified hypertensive disorder · No
|
99 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
103 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
199 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Chorioamnionitis · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Chorioamnionitis · No
|
99 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
103 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
199 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Puerperal sepsis · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
2 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Puerperal sepsis · No
|
99 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
104 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
199 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Endometritis · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Endometritis · No
|
99 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
104 Obtainable pregnancy outcomes
|
50 Obtainable pregnancy outcomes
|
199 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Peripartum hemorrhage · Yes
|
2 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Peripartum hemorrhage · No
|
97 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Antepartum hemorrhage · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
2 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
2 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Antepartum hemorrhage · No
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
102 Obtainable pregnancy outcomes
|
50 Obtainable pregnancy outcomes
|
197 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Intrapartum hemorrhage · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
3 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Intrapartum hemorrhage · No
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
104 Obtainable pregnancy outcomes
|
50 Obtainable pregnancy outcomes
|
196 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Postpartum hemorrhage · Yes
|
2 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
2 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
4 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Postpartum hemorrhage · No
|
97 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
102 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
195 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Preterm premature rupture of membranes (PPROM) · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
3 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Preterm premature rupture of membranes (PPROM) · No
|
99 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
103 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
196 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Fever of unclear etiology · Yes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Fever of unclear etiology · No
|
99 Obtainable pregnancy outcomes
|
49 Obtainable pregnancy outcomes
|
104 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
199 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Other complication · Yes
|
1 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
4 Obtainable pregnancy outcomes
|
0 Obtainable pregnancy outcomes
|
2 Obtainable pregnancy outcomes
|
1 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pregnancy Complications: Frequency of Pregnancy Complications
Other complication · No
|
98 Obtainable pregnancy outcomes
|
48 Obtainable pregnancy outcomes
|
100 Obtainable pregnancy outcomes
|
51 Obtainable pregnancy outcomes
|
197 Obtainable pregnancy outcomes
|
47 Obtainable pregnancy outcomes
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at the 2-week post pregnancy outcome (PPO) visitPopulation: Enrolled infants with an analyzable sample collected at the PPO visit.
Infant blood TFV-DP was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a TFV-DP concentration above the lower limit of quantification (LLOQ) for the assay.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=44 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=50 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=43 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)
|
30 Participants
|
35 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: measured at the 2-week post pregnancy outcome (PPO) visitPopulation: Enrolled infants with an analyzable sample collected at the PPO visit.
Infant blood FTC-TP was measured at infants' PPO visit. The outcome is defined as having detectable drug level, with detectable drug levels defined as a FTC-TP concentration above the lower limit of quantification (LLOQ) for the assay.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=44 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=50 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=43 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)
|
7 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: measured at the 2-week post pregnancy outcome (PPO) visitPopulation: Enrolled infants with an analyzable sample collected at the PPO visit.
Infant plasma DPV concentration was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a DPV concentration above the lower limit of quantification (LLOQ) for the assay.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=94 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=97 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=182 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infant Drug Levels: Number of Infants With Detectable Plasma DPV
|
22 Participants
|
31 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohortPopulation: Participants enrolled and randomized to the Truvada Tablet arm who had at least one analyzable blood TFV-DP sample collected during study follow-up.
Maternal blood TFV-DP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants. Participants are categorized as ever being exposed if they had at least one measure that was \>= 200 fmol/punch (if the sample was collected more than 6 weeks after randomization) or \>= 150 fmol/punch (if the sample was collected within 6 weeks of randomization). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=15 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=51 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=49 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adherence: Maternal Blood TFV-DP Concentrations
Ever exposed
|
8 Participants
|
37 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Maternal Blood TFV-DP Concentrations
Never exposed
|
7 Participants
|
14 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohortPopulation: Participants enrolled and randomized to the Truvada Tablet arm who had an analyzable blood FTC-TP sample collected during at their PPO visit.
Maternal blood FTC-TP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=14 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=47 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=45 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adherence: Maternal Blood FTC-TP Concentrations
|
0.1 pmol
Standard Deviation 0.2
|
0 pmol
Standard Deviation 0
|
0 pmol
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohortPopulation: Participants enrolled and randomized to the VR arm who had at least one analyzable plasma DPV sample collected during study follow-up.
Maternal plasma DPV was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for a randomly selected subset of participants (approximately 50%) randomized to receive the VR. Participants are categorized as ever being exposed if they had at least one measure that was greater than the LLOQ (i.e., greater than or equal to 20 pg/mL). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=48 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=52 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=100 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adherence: Maternal Plasma DPV Concentrations
|
43 Participants
|
51 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Week 4 and PPO visitsPopulation: Participants enrolled and randomized to the Truvada Tablet arm.
Based on participant report, as defined by self-reported missed doses for oral Truvada. This was only reported by participants in Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=51 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=49 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adherence: Frequency of Missing Taking the Pills
Week 4 Visit · Never
|
36 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Missing Taking the Pills
Week 4 Visit · Rarely
|
8 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Missing Taking the Pills
Week 4 Visit · Often
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Missing Taking the Pills
Week 4 Visit · Missing
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Missing Taking the Pills
PPO Visit · Never
|
39 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Missing Taking the Pills
PPO Visit · Rarely
|
6 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Missing Taking the Pills
PPO Visit · Often
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Missing Taking the Pills
PPO Visit · Missing
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohortPopulation: Participants enrolled and randomized to the VR arm who had at least one analyzable residual drug level collected during study follow-up.
Residual drug levels were collected from returned VRs, which were expected to be returned at monthly visits throughout study follow-up. Drug release rate was calculated by subtracting the residual level from the amount of residual drug in the manufacturer lot, divided by the number of days the participant was expected to use that ring, times 28 days. For each individual ring, a ring was considered to show evidence of use if the residual drug level was greater than or equal to 0.9mg/28 days of use. Participants are categorized as either ever being exposed or never being exposed to product over the course of study follow-up. They are categorized as ever being exposed to product if they had at least one ring with evidence of use (i.e., greater than or equal to 0.9 mg/28 days of release). They are categorized as never being exposed if they had at least one analyzable returned ring and none of these rings had evidence of use.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=97 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=105 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=199 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)
|
95 Participants
|
93 Participants
|
193 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Week 4 and 6-Week PPO/SEV visits.Population: Participants enrolled and randomized.
Based on participant report of whether they would be willing to use the study product they were randomized to receive when pregnant in the future. Only asked of participants in Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=106 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=51 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=199 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=49 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
6-Week PPO Visit/SEV · Not sure
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
Week 4 Visit · Yes
|
98 Participants
|
42 Participants
|
193 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
Week 4 Visit · No
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
Week 4 Visit · Not sure
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
Week 4 Visit · N/A: doesn't plan to have future pregnancies
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
Week 4 Visit · Missing
|
3 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
6-Week PPO Visit/SEV · Yes
|
94 Participants
|
46 Participants
|
190 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
6-Week PPO Visit/SEV · No
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
6-Week PPO Visit/SEV · N/A: doesn't plan to have future pregnancies
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
6-Week PPO Visit/SEV · Missing
|
5 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Week 4 visits.Population: Participants enrolled and randomized.
Based on participant report of how much they liked or disliked the study product they were randomized to receive for HIV prevention, and of how much they liked or disliked male condoms for HIV prevention. Only asked of participants in Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=106 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=51 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=202 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=49 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike male condoms for HIV prevention · Dislike very much
|
23 Participants
|
5 Participants
|
25 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike male condoms for HIV prevention · Dislike
|
30 Participants
|
19 Participants
|
96 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike male condoms for HIV prevention · Neither like nor dislike
|
10 Participants
|
8 Participants
|
25 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike male condoms for HIV prevention · Like
|
28 Participants
|
12 Participants
|
45 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike male condoms for HIV prevention · Like very much
|
12 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike male condoms for HIV prevention · Missing
|
3 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike the [pills/ring] for HIV prevention · Dislike very much
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike the [pills/ring] for HIV prevention · Dislike
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike the [pills/ring] for HIV prevention · Neither like nor dislike
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike the [pills/ring] for HIV prevention · Like
|
47 Participants
|
29 Participants
|
122 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike the [pills/ring] for HIV prevention · Like very much
|
51 Participants
|
12 Participants
|
70 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
How much do you like or dislike the [pills/ring] for HIV prevention · Missing
|
3 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Week 4 visit and Post-Pregnancy Outcome (PPO) (occurring within 2 weeks of pregnancy outcome) visitPopulation: Participants enrolled and randomized to the Truvada Tablet arm.
Based on participant report, as defined by self-reported occurrences of the ring being out of the vagina for more than 12 hours, being out for any time. This was only reported by participants in Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=106 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=202 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out for >12 hours in past 4 weeks - Week 4 Visit · Never
|
101 Participants
|
190 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out for >12 hours in past 4 weeks - Week 4 Visit · Rarely
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out for >12 hours in past 4 weeks - Week 4 Visit · Often
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out for >12 hours in past 4 weeks - Week 4 Visit · Missing
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out for >12 hours in past 4 weeks - PPO Visit · Never
|
93 Participants
|
145 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out for >12 hours in past 4 weeks - PPO Visit · Rarely
|
7 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out for >12 hours in past 4 weeks - PPO Visit · Often
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out for >12 hours in past 4 weeks - PPO Visit · Missing
|
6 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out, even briefly, in past 4 weeks - Week 4 Visit · Never
|
101 Participants
|
184 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out, even briefly, in past 4 weeks - Week 4 Visit · Rarely
|
1 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out, even briefly, in past 4 weeks - Week 4 Visit · Often
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out, even briefly, in past 4 weeks - Week 4 Visit · Missing
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out, even briefly, in past 4 weeks - PPO Visit · Never
|
91 Participants
|
121 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out, even briefly, in past 4 weeks - PPO Visit · Rarely
|
9 Participants
|
66 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out, even briefly, in past 4 weeks - PPO Visit · Often
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adherence: Frequency of Ring Removal/Expulsion
Ring out, even briefly, in past 4 weeks - PPO Visit · Missing
|
6 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Week 4 visits.Population: Participants enrolled and randomized.
Based on participant report of how satisfied they have been with the the study product they were randomized to receive for HIV prevention. Only asked of participants in Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=104 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=48 Participants
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=199 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=49 Participants
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV
Dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV
Very satisfied
|
68 Participants
|
27 Participants
|
125 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV
Satisfied
|
34 Participants
|
17 Participants
|
73 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV
Neutral
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV
Very dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV
Missing
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Cohort 1 Mothers: Truvada Tablet
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Serious events: 8 serious events
Other events: 73 other events
Deaths: 0 deaths
Cohort 2 Mothers: Truvada Tablet
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Serious events: 11 serious events
Other events: 169 other events
Deaths: 0 deaths
Cohort 3 Mothers: Truvada Tablet
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Serious events: 14 serious events
Other events: 91 other events
Deaths: 0 deaths
Cohort 1 Infants: Truvada Tablet
Serious events: 7 serious events
Other events: 39 other events
Deaths: 1 deaths
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Serious events: 22 serious events
Other events: 92 other events
Deaths: 4 deaths
Cohort 2 Infants: Truvada Tablet
Serious events: 5 serious events
Other events: 44 other events
Deaths: 0 deaths
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Serious events: 30 serious events
Other events: 176 other events
Deaths: 4 deaths
Cohort 3 Infants: Truvada Tablet
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=101 participants at risk
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=49 participants at risk
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=106 participants at risk
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=51 participants at risk
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=202 participants at risk
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Truvada Tablet
n=49 participants at risk
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=99 participants at risk
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
n=48 participants at risk
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=103 participants at risk
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
n=51 participants at risk
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=197 participants at risk
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
n=48 participants at risk
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Congenital absence of bile ducts
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Dysmorphism
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Pectus excavatum
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Face oedema
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Amniotic cavity infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
4/103 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/197 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
COVID-19
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Dysentery
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/197 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Malaria
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/197 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Neonatal pneumonia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
4/103 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
6/197 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/197 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Metabolism and nutrition disorders
Neonatal hypocalcaemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia haemorrhage
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Meconium aspiration syndrome
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemosiderosis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Transient tachypnoea of the newborn
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
Other adverse events
| Measure |
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=101 participants at risk
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Mothers: Truvada Tablet
n=49 participants at risk
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
|
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=106 participants at risk
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Mothers: Truvada Tablet
n=51 participants at risk
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
n=202 participants at risk
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
|
Cohort 3 Mothers: Truvada Tablet
n=49 participants at risk
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
|
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=99 participants at risk
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 1 Infants: Truvada Tablet
n=48 participants at risk
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
|
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=103 participants at risk
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 2 Infants: Truvada Tablet
n=51 participants at risk
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
|
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
n=197 participants at risk
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
|
Cohort 3 Infants: Truvada Tablet
n=48 participants at risk
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
3/101 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
12/202 • Number of events 12 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.8%
3/106 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.5%
9/202 • Number of events 9 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Birth mark
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Congenital absence of bile ducts
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Congenital inguinal hernia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Congenital umbilical hernia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.6%
7/197 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Nail aplasia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Congenital, familial and genetic disorders
Tethered oral tissue
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Eye disorders
Blepharitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.9%
3/103 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/197 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Eye disorders
Conjunctivitis allergic
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Eye disorders
Retinopathy of prematurity
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/202 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/202 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/202 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
6/99 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
14.6%
7/48 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.7%
9/103 • Number of events 9 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
7.6%
15/197 • Number of events 15 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
12.5%
6/48 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/202 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Enteritis
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/197 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.9%
14/202 • Number of events 14 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Infantile colic
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
16.3%
8/49 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
18.4%
9/49 • Number of events 9 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
11.8%
6/51 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Asthenia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Developmental delay
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Fatigue
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Generalised oedema
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Pyrexia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.1%
5/99 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
4/103 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/197 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
General disorders
Suprapubic pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Abscess of eyelid
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
3/99 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Bacterial infection
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Body tinea
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
3/99 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/197 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Bullous impetigo
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
COVID-19
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
4/103 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
12/197 • Number of events 12 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.3%
4/48 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
3/99 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.9%
3/103 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
8/197 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Dysentery
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Endometritis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Furuncle
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Gastroenteritis
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.4%
11/202 • Number of events 11 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
15.2%
15/99 • Number of events 15 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
14.6%
7/48 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
25.2%
26/103 • Number of events 26 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
25.5%
13/51 • Number of events 13 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
26.4%
52/197 • Number of events 52 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
29.2%
14/48 • Number of events 14 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Genitourinary chlamydia infection
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.8%
4/106 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
8/202 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Hookworm infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Impetigo
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.9%
3/103 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/197 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Influenza
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/202 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
8/197 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
4/103 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/197 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Malaria
|
3.0%
3/101 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/202 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.9%
5/103 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/197 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Mastitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
6/202 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.6%
7/197 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Ophthalmia neonatorum
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.1%
5/99 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
7.8%
4/51 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
7.6%
15/197 • Number of events 15 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.3%
4/48 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Otitis media
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
3/99 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.9%
3/103 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/197 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.3%
4/48 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Paronychia
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Pharyngitis
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/197 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
4/103 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
10.7%
21/197 • Number of events 21 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Postoperative wound infection
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Postpartum sepsis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Rhinitis
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.1%
5/99 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.9%
3/103 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Schistosomiasis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Septic rash
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Syphilis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
4/99 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/197 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
3/101 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
11.3%
12/106 • Number of events 12 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
13.7%
7/51 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
17.8%
36/202 • Number of events 36 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
14.3%
7/49 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
54.5%
54/99 • Number of events 54 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
47.9%
23/48 • Number of events 23 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
60.2%
62/103 • Number of events 62 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
64.7%
33/51 • Number of events 33 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
64.5%
127/197 • Number of events 127 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
50.0%
24/48 • Number of events 24 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.5%
9/106 • Number of events 9 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
9.8%
5/51 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
12/202 • Number of events 12 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.2%
4/49 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Varicella
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Viraemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/197 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Viral rash
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.0%
10/202 • Number of events 10 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Vulvovaginitis
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
7.5%
8/106 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.4%
13/202 • Number of events 13 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/202 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Wound cellulitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Anal injury
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Foreign body in ear
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Incision site discharge
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Uterine cervical laceration
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/202 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.8%
3/106 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.9%
3/103 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/197 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Blood pressure increased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Creatinine renal clearance decreased
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.7%
6/106 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
9.9%
20/202 • Number of events 20 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Haemoglobin decreased
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.5%
7/202 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.9%
3/103 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
6/197 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.8%
3/106 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/202 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.8%
3/106 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/202 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Metabolism and nutrition disorders
Neonatal hypocalcaemia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
34.3%
34/99 • Number of events 34 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
33.3%
16/48 • Number of events 16 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
43.7%
45/103 • Number of events 45 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
27.5%
14/51 • Number of events 14 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
24.4%
48/197 • Number of events 48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
22.9%
11/48 • Number of events 11 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/202 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
3/101 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.8%
3/106 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
8/202 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Dizziness
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
16.3%
8/49 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Headache
|
4.0%
4/101 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.7%
6/106 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
7.8%
4/51 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
12/202 • Number of events 12 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Migraine
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Sciatica
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.0%
10/202 • Number of events 10 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Breech presentation
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Caput succedaneum
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalhaematoma
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
6.9%
7/101 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.8%
4/106 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/202 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.8%
3/106 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.4%
11/202 • Number of events 11 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
3.0%
3/101 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.7%
5/106 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
11.8%
6/51 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
7.9%
16/202 • Number of events 16 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
12.2%
6/49 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Intrapartum haemorrhage
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
7.1%
7/99 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
9.7%
10/103 • Number of events 10 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
9.8%
5/51 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
8/197 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.3%
4/48 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Morning sickness
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Obstructed labour
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/202 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Polyhydramnios
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Post abortion haemorrhage
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/202 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.7%
5/106 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
7.8%
4/51 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/202 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/202 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.5%
3/202 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged rupture of membranes
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Pregnancy, puerperium and perinatal conditions
Small for dates baby
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
15.2%
15/99 • Number of events 15 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
18.8%
9/48 • Number of events 9 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
28.2%
29/103 • Number of events 29 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
25.5%
13/51 • Number of events 13 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
25.9%
51/197 • Number of events 51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
20.8%
10/48 • Number of events 10 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Psychiatric disorders
Perinatal depression
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Renal and urinary disorders
Dysuria
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.5%
7/202 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
6/202 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.7%
5/106 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
12/202 • Number of events 12 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Renal and urinary disorders
Urethral perforation
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Genital cyst
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Lactation insufficiency
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Uterine pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Uterine tenderness
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/202 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.0%
10/202 • Number of events 10 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.2%
4/49 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.0%
8/202 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Meconium aspiration syndrome
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/197 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Respiratory, thoracic and mediastinal disorders
Transient tachypnoea of the newborn
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
8.1%
8/99 • Number of events 8 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.8%
6/103 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.6%
7/197 • Number of events 7 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.1%
5/99 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
6/197 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/197 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
6/197 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.9%
3/103 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/197 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
4/197 • Number of events 4 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.0%
2/197 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.99%
1/101 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Transient neonatal pustular melanosis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.51%
1/197 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Umbilical discharge
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.5%
5/197 • Number of events 5 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Vascular disorders
Hypertension
|
2.0%
2/101 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
3.0%
6/202 • Number of events 6 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
1.9%
2/106 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.99%
2/202 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/106 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/101 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.94%
1/106 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/202 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/49 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/99 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/103 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/51 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/197 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
0.00%
0/48 • Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place