Trial Outcomes & Findings for Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum (NCT NCT03386578)
NCT ID: NCT03386578
Last Updated: 2025-02-19
Results Overview
TFV-DP concentration levels were measured using dried blood spots (DBS) collected weekly during pregnancy and postpartum. These concentrations accumulated each week, and the plateau observed in the concentration-time curve represents the steady-state TFV-DP concentration, achieved at week 12. Predicted TFV-DP concentration levels for each maternal participant were obtained using a population PK model, and descriptive statistics were generated. The estimated steady-state TFV-DP concentration threshold for optimal adherence during pregnancy and postpartum is the 25th percentile when taking 7 doses per week. For more details, refer to the published paper (PubMed ID: 33341883).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
780 participants
Primary outcome timeframe
Measured from study week 1 to study week 12 during pregnancy for Maternal PK Component Group 1 and from study week 1 to study week 12 during postpartum for Maternal PK Component Group 2
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
Maternal PK Component Group 1
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PrEP Comparison Cohort 1
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 1
Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 2
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
|
Infant PK Component Group 1
Infants born to women in PK Component Group 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
Infant PK Component Group 2
Infants born to women in PK Component Group 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through breastmilk transfer.
|
Infant PrEP Comparison Cohort 1
Infants born to women in PrEP Comparison Cohort 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
Infant PrEP Comparison Cohort 2/Step 1
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
|
Infant PrEP Comparison Cohort 2/Step 2
Infants born to women in PrEP Comparison Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Component
STARTED
|
20
|
20
|
0
|
0
|
0
|
20
|
20
|
0
|
0
|
0
|
|
PK Component
COMPLETED
|
20
|
19
|
0
|
0
|
0
|
18
|
19
|
0
|
0
|
0
|
|
PK Component
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
|
PrEP Comparison Component Step 1
STARTED
|
0
|
0
|
229
|
121
|
0
|
0
|
0
|
229
|
121
|
0
|
|
PrEP Comparison Component Step 1
COMPLETED
|
0
|
0
|
202
|
95
|
0
|
0
|
0
|
196
|
88
|
0
|
|
PrEP Comparison Component Step 1
NOT COMPLETED
|
0
|
0
|
27
|
26
|
0
|
0
|
0
|
33
|
33
|
0
|
|
PrEP Comparison Component Step 2
STARTED
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
13
|
|
PrEP Comparison Component Step 2
COMPLETED
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
13
|
|
PrEP Comparison Component Step 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Maternal PK Component Group 1
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PrEP Comparison Cohort 1
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 1
Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 2
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
|
Infant PK Component Group 1
Infants born to women in PK Component Group 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
Infant PK Component Group 2
Infants born to women in PK Component Group 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through breastmilk transfer.
|
Infant PrEP Comparison Cohort 1
Infants born to women in PrEP Comparison Cohort 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
Infant PrEP Comparison Cohort 2/Step 1
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
|
Infant PrEP Comparison Cohort 2/Step 2
Infants born to women in PrEP Comparison Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Component
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
PK Component
Stillbirth/Abortion
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
PrEP Comparison Component Step 1
Lost to Follow-up
|
0
|
0
|
17
|
9
|
0
|
0
|
0
|
7
|
5
|
0
|
|
PrEP Comparison Component Step 1
Withdrawal by Subject
|
0
|
0
|
9
|
4
|
0
|
0
|
0
|
5
|
1
|
0
|
|
PrEP Comparison Component Step 1
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
9
|
5
|
0
|
|
PrEP Comparison Component Step 1
Enrolled to Cohort 2/Step 2
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
13
|
0
|
|
PrEP Comparison Component Step 1
Stillbirth/Abortion
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
0
|
|
PrEP Comparison Component Step 1
Maternal Off-study During Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
5
|
0
|
Baseline Characteristics
Baseline age is reported separately for PK Component and PrEP Comparison Component participants.
Baseline characteristics by cohort
| Measure |
Maternal PK Component Group 2
n=20 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PrEP Comparison Cohort 1
n=229 Participants
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 1
n=121 Participants
Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 2
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
|
Total
n=390 Participants
Total of all reporting groups
|
Maternal PK Component Group 1
n=20 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|---|---|---|---|
|
Age, Continuous
PK Component
|
20 years
n=20 Participants • Baseline age is reported separately for PK Component and PrEP Comparison Component participants.
|
—
|
—
|
—
|
20 years
n=40 Participants • Baseline age is reported separately for PK Component and PrEP Comparison Component participants.
|
20 years
n=20 Participants • Baseline age is reported separately for PK Component and PrEP Comparison Component participants.
|
|
Age, Continuous
PrEP Comparison
|
—
|
21 years
n=229 Participants • Baseline age is reported separately for PK Component and PrEP Comparison Component participants.
|
21 years
n=121 Participants • Baseline age is reported separately for PK Component and PrEP Comparison Component participants.
|
—
|
21 years
n=350 Participants • Baseline age is reported separately for PK Component and PrEP Comparison Component participants.
|
—
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
229 Participants
n=229 Participants
|
121 Participants
n=121 Participants
|
0 Participants
|
390 Participants
n=390 Participants
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=229 Participants
|
0 Participants
n=121 Participants
|
0 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=229 Participants
|
0 Participants
n=121 Participants
|
0 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=229 Participants
|
0 Participants
n=121 Participants
|
0 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=229 Participants
|
0 Participants
n=121 Participants
|
0 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=20 Participants
|
229 Participants
n=229 Participants
|
121 Participants
n=121 Participants
|
0 Participants
|
390 Participants
n=390 Participants
|
20 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=229 Participants
|
0 Participants
n=121 Participants
|
0 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=229 Participants
|
0 Participants
n=121 Participants
|
0 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=229 Participants
|
0 Participants
n=121 Participants
|
0 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
Malawi
|
7 participants
n=20 Participants
|
23 participants
n=229 Participants
|
27 participants
n=121 Participants
|
—
|
57 participants
n=390 Participants
|
0 participants
n=20 Participants
|
|
Region of Enrollment
South Africa
|
0 participants
n=20 Participants
|
29 participants
n=229 Participants
|
11 participants
n=121 Participants
|
—
|
44 participants
n=390 Participants
|
4 participants
n=20 Participants
|
|
Region of Enrollment
Uganda
|
4 participants
n=20 Participants
|
54 participants
n=229 Participants
|
23 participants
n=121 Participants
|
—
|
89 participants
n=390 Participants
|
8 participants
n=20 Participants
|
|
Region of Enrollment
Zimbabwe
|
9 participants
n=20 Participants
|
123 participants
n=229 Participants
|
60 participants
n=121 Participants
|
—
|
200 participants
n=390 Participants
|
8 participants
n=20 Participants
|
|
Gestational Age
PK Component
|
—
|
—
|
—
|
—
|
18 weeks
n=20 Participants • Baseline gestational age is reported separately for PK Component and PrEP Comparison Component participants. PK Component Group 2 participants were enrolled during postpartum.
|
18 weeks
n=20 Participants • Baseline gestational age is reported separately for PK Component and PrEP Comparison Component participants. PK Component Group 2 participants were enrolled during postpartum.
|
|
Gestational Age
PrEP Comparison
|
—
|
24 weeks
n=229 Participants • Baseline gestational age is reported separately for PK Component and PrEP Comparison Component participants. PK Component Group 2 participants were enrolled during postpartum.
|
25 weeks
n=121 Participants • Baseline gestational age is reported separately for PK Component and PrEP Comparison Component participants. PK Component Group 2 participants were enrolled during postpartum.
|
—
|
24 weeks
n=350 Participants • Baseline gestational age is reported separately for PK Component and PrEP Comparison Component participants. PK Component Group 2 participants were enrolled during postpartum.
|
—
|
PRIMARY outcome
Timeframe: Measured from study week 1 to study week 12 during pregnancy for Maternal PK Component Group 1 and from study week 1 to study week 12 during postpartum for Maternal PK Component Group 2Population: Mothers from PK Component were included in this outcome measure.
TFV-DP concentration levels were measured using dried blood spots (DBS) collected weekly during pregnancy and postpartum. These concentrations accumulated each week, and the plateau observed in the concentration-time curve represents the steady-state TFV-DP concentration, achieved at week 12. Predicted TFV-DP concentration levels for each maternal participant were obtained using a population PK model, and descriptive statistics were generated. The estimated steady-state TFV-DP concentration threshold for optimal adherence during pregnancy and postpartum is the 25th percentile when taking 7 doses per week. For more details, refer to the published paper (PubMed ID: 33341883).
Outcome measures
| Measure |
Maternal PK Component Group 1
n=20 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=20 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Estimated Threshold of Maternal Steady-state Tenofovir Diphosphate (TFV-DP) Concentration Levels Corresponding to Optimal Adherence in the PK Component
|
965 fmol/punch
|
1050 fmol/punch
|
PRIMARY outcome
Timeframe: Antepartum study week 4Population: Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=194 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 4
|
0.15 proportion of participants
Interval 0.11 to 0.21
|
—
|
PRIMARY outcome
Timeframe: Antepartum study week 8Population: Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=159 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 8
|
0.23 proportion of participants
Interval 0.16 to 0.3
|
—
|
PRIMARY outcome
Timeframe: Antepartum study week 12Population: Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=95 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 12
|
0.27 proportion of participants
Interval 0.19 to 0.37
|
—
|
PRIMARY outcome
Timeframe: DeliveryPopulation: Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=143 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Proportion of Mothers With Optimal Adherence at Delivery
|
0.31 proportion of participants
Interval 0.23 to 0.39
|
—
|
PRIMARY outcome
Timeframe: Postpartum Week 6Population: Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=168 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Proportion of Mothers With Optimal Adherence at Postpartum Week 6
|
0.20 proportion of participants
Interval 0.14 to 0.27
|
—
|
PRIMARY outcome
Timeframe: Postpartum week 14Population: Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=161 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Proportion of Mothers With Optimal Adherence at Postpartum Week 14
|
0.17 proportion of participants
Interval 0.12 to 0.24
|
—
|
PRIMARY outcome
Timeframe: Postpartum Week 26Population: Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=110 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Proportion of Mothers With Optimal Adherence at Postpartum Week 26
|
0.15 proportion of participants
Interval 0.09 to 0.23
|
—
|
PRIMARY outcome
Timeframe: Study entry through 26 weeks postpartum, up to one yearPopulation: Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) with PK data from any study visits were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=1032 Visits
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Proportion of Maternal Visits With Optimal Adherence During Study Follow-up
|
0.21 proportion of visits
Interval 0.18 to 0.23
|
—
|
PRIMARY outcome
Timeframe: Study entry through 26 weeks postpartum, up to one yearPopulation: Mothers from the PrEP Comparison Component were included in the analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group. The incidence of adverse events was calculated per 100 person-years. Maternal participants in Cohort 2/Step 2 contributed to person-years for both groups, with Cohort 2/Step 1 censored upon enrollment in Step 2.
Adverse events (AEs) were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. Maternal AEs were defined as the occurrence of at least one grade 2 (moderate) chemistry abnormality, or one grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event, during the study follow-up.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=242 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=121 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Incidence Rate of Maternal Adverse Events Per 100 Person-years
|
29.4 number of new cases per 100 person years
Interval 22.1 to 36.0
|
18.2 number of new cases per 100 person years
Interval 11.0 to 30.2
|
PRIMARY outcome
Timeframe: Measured at deliveryPopulation: Mothers from PrEP Comparison Component with available pregnancy outcome data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Adverse outcomes are defined as at least one of the following: spontaneous abortion (less than 20 weeks gestation), stillbirth (greater than or equal to 20 weeks gestation), preterm delivery (less than 37 weeks), or small for gestational age (less than 10th percentile using INTERGROWTH-21 norms)
Outcome measures
| Measure |
Maternal PK Component Group 1
n=216 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=108 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Number of Composite Adverse Pregnancy Outcomes
|
51 participants
|
28 participants
|
PRIMARY outcome
Timeframe: From birth through week 26Population: Live-born infants from PrEP Comparison Component were included in the analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group. The incidence of adverse events was calculated per 100 person-years. Infant participants in Cohort 2/Step 2 contributed to person-years for both groups, with Cohort 2/Step 1 censored upon enrollment in Step 2.
Adverse events were assessed according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. An infant grade 3 or higher adverse event was defined as a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=230 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=112 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Incidence Rate of Infant Grade 3 or Higher Adverse Events Per 100 Person-years
|
42.6 number of new cases per 100 person years
Interval 29.6 to 61.2
|
33.1 number of new cases per 100 person years
Interval 18.4 to 59.7
|
PRIMARY outcome
Timeframe: Measured at birthPopulation: Infants from PrEP Comparison Component with available DXA data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the whole body (WB-BMC)
Outcome measures
| Measure |
Maternal PK Component Group 1
n=128 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=74 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Bone Mineral Content of Whole Body at Birth
|
68.2 gram
Standard Deviation 13.3
|
65.8 gram
Standard Deviation 12.0
|
PRIMARY outcome
Timeframe: Measured at birthPopulation: Infants from PrEP Comparison Component with available DXA data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine (LS-BMC)
Outcome measures
| Measure |
Maternal PK Component Group 1
n=107 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=73 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Bone Mineral Content of Lumbar Spine at Birth
|
1.9 gram
Standard Deviation 0.5
|
1.8 gram
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Measured at week 26 post-birthPopulation: Infants from PrEP Comparison Component with available DXA data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine (LS-BMC)
Outcome measures
| Measure |
Maternal PK Component Group 1
n=131 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=48 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Bone Mineral Content of Lumbar Spine at Week 26
|
3.2 gram
Standard Deviation 0.6
|
3.1 gram
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Measured at birthPopulation: Infants from PrEP Comparison Component with available creatinine data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Infant creatinine levels were obtained from the chemistry/hematology test results at the birth visit
Outcome measures
| Measure |
Maternal PK Component Group 1
n=192 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=95 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Creatinine Levels at Birth in the PrEP Comparison Component
|
0.4 mg/dL
Standard Deviation 0.2
|
0.3 mg/dL
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: Measured at week 26 post-birthPopulation: Infants from PrEP Comparison Component with available creatinine data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Infant creatinine levels were obtained from the chemistry/hematology test results at week 26 visit
Outcome measures
| Measure |
Maternal PK Component Group 1
n=206 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=87 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Creatinine Levels at Week 26 in the PrEP Comparison Component
|
0.2 mg/dL
Standard Deviation 0.0
|
0.2 mg/dL
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Measured at birthPopulation: Infants from PrEP Comparison Component with available creatinine clearance data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
The infant creatinine clearance (CrCl) rate was calculated using creatinine levels and length based on the Schwartz equation.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=192 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=95 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Creatinine Clearance (CrCl) Rate at Birth in the PrEP Comparison Component
|
84.4 mL/min
Standard Deviation 61.6
|
74.6 mL/min
Standard Deviation 33.7
|
PRIMARY outcome
Timeframe: Measured at week 26 post-birthPopulation: Infants from PrEP Comparison Component with available creatinine clearance data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
The infant creatinine clearance (CrCl) rate was calculated using creatinine levels and length based on the Schwartz equation.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=205 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=86 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Creatinine Clearance (CrCl) Rate at Week 26 in the PrEP Comparison Component
|
143.3 mL/min
Standard Deviation 42.5
|
140.1 mL/min
Standard Deviation 37.3
|
PRIMARY outcome
Timeframe: Measured at birthPopulation: Infants from PrEP Comparison Component with available length-for-age z-score data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
The infant length-for-age Z-score was calculated based on the infant's sex, length, and age (in days) using WHO child growth standards. The Z-scores range from a minimum of -6 to a maximum of +6. Higher Z-scores indicate better outcomes, reflecting closer adherence to the WHO standards for infant length-for-age. A Z-score of 0 means that the infant's length is exactly at the mean length of the reference population. Z-score between -2 and +2 is considered normal or average. Infants within this range are typically seen as having an appropriate length for their age. Z-score \< -3 is a threshold to identify severe stunting, indicating that the infant's length is significantly below the average and pointing to severe chronic undernutrition or other serious health concerns.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=197 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=97 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Length-for-age Z-score at Birth
|
-0.4 Z-score
Standard Deviation 1.4
|
-0.6 Z-score
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Measured at week 26 post-birthPopulation: Infants from PrEP Comparison Component with available length-for-age z-score data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
The infant length-for-age z-score was calculated based on the infant's sex, length, and age (in days) using WHO child growth standards. The z-scores range from a minimum of -6 to a maximum of +6. Higher z-scores indicate better outcomes, reflecting closer adherence to the WHO standards for infant length-for-age. A Z-score of 0 means that the infant's length is exactly at the mean length of the reference population. Z-score between -2 and +2 is considered normal or average. Infants within this range are typically seen as having an appropriate length for their age. Z-score \< -3 is a threshold to identify severe stunting, indicating that the infant's length is significantly below the average and pointing to severe chronic undernutrition or other serious health concerns.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=205 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=87 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Mean Infant Length-for-age Z-score at Week 26
|
-0.6 Z-score
Standard Deviation 1.2
|
-0.8 Z-score
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Assessed at study Week 12 during pregnancy for Maternal PK Component Group 1 and at study Week 12 during postpartum for Maternal PK Component Group 2Population: Evaluable participants from PK Components were included in the analysis.
TFV-DP concentration levels were measured using dried blood spots (DBS). Concentrations measured at week 12 represent the steady-state TFV-DP concentration.
Outcome measures
| Measure |
Maternal PK Component Group 1
n=20 Participants
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=20 Participants
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
|---|---|---|
|
Maternal Median Steady State TFV-DP Concentration Levels at Study Week 12 During Pregnancy and Postpartum
|
965 fmol/punch
Interval 691.0 to 1166.0
|
1406 fmol/punch
Interval 1053.0 to 1859.0
|
Adverse Events
Maternal PK Component Group 1
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Maternal PK Component Group 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Maternal PrEP Comparison Cohort 1
Serious events: 30 serious events
Other events: 123 other events
Deaths: 1 deaths
Maternal PrEP Comparison Cohort 2/Step 1
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Maternal PrEP Comparison Cohort 2/Step 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Infant PK Component Group 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Infant PK Component Group 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Infant PrEP Comparison Cohort 1
Serious events: 26 serious events
Other events: 120 other events
Deaths: 9 deaths
Infant PrEP Comparison Cohort 2/Step 1
Serious events: 8 serious events
Other events: 44 other events
Deaths: 5 deaths
Infant PrEP Comparison Cohort 2/Step 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maternal PK Component Group 1
n=20 participants at risk
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=20 participants at risk
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PrEP Comparison Cohort 1
n=229 participants at risk
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 1
n=121 participants at risk
Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 2
n=13 participants at risk
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
|
Infant PK Component Group 1
n=18 participants at risk
Infants born to women in PK Component Group 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
Infant PK Component Group 2
n=20 participants at risk
Infants born to women in PK Component Group 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through breastmilk transfer.
|
Infant PrEP Comparison Cohort 1
n=217 participants at risk
Infants born to women in PrEP Comparison Cohort 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
Infant PrEP Comparison Cohort 2/Step 1
n=112 participants at risk
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study
|
Infant PrEP Comparison Cohort 2/Step 2
n=13 participants at risk
Infants born to women in PrEP Comparison Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Congenital, familial and genetic disorders
Birth mark
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Congenital, familial and genetic disorders
Gastroschisis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Haemoperitoneum
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
General disorders
Death neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.8%
2/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
General disorders
Fever neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Amniotic cavity infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Endometritis
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Malaria
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Sepsis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.7%
8/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.7%
3/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Apgar score low
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Progesterone decreased
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.4%
3/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
4/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Eclampsia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Failed induction of labour
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
4/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal malpresentation
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Hypoxic ischaemic encephalopathy neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.4%
3/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.8%
2/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Placenta accreta
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
4/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord around neck
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoea
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Meconium aspiration syndrome
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.4%
3/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
5.6%
1/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.8%
4/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
Other adverse events
| Measure |
Maternal PK Component Group 1
n=20 participants at risk
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PK Component Group 2
n=20 participants at risk
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
|
Maternal PrEP Comparison Cohort 1
n=229 participants at risk
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 1
n=121 participants at risk
Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
|
Maternal PrEP Comparison Cohort 2/Step 2
n=13 participants at risk
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
|
Infant PK Component Group 1
n=18 participants at risk
Infants born to women in PK Component Group 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
Infant PK Component Group 2
n=20 participants at risk
Infants born to women in PK Component Group 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through breastmilk transfer.
|
Infant PrEP Comparison Cohort 1
n=217 participants at risk
Infants born to women in PrEP Comparison Cohort 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
Infant PrEP Comparison Cohort 2/Step 1
n=112 participants at risk
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study
|
Infant PrEP Comparison Cohort 2/Step 2
n=13 participants at risk
Infants born to women in PrEP Comparison Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Blood and lymphatic system disorders
Thrombocytopenia neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.2%
5/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.8%
2/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.2%
5/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
4/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.4%
3/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.3%
3/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.9%
9/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
4/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.5%
3/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Infantile colic
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Infantile diarrhoea
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.6%
6/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.7%
1/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
General disorders
Asthenia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.3%
3/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
General disorders
Malaise
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
General disorders
Pyrexia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Abscess of external ear
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Body tinea
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Breast abscess
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.8%
2/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.1%
7/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.5%
3/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
4.6%
10/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.8%
2/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Genital ulcer syndrome
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Gynaecological chlamydia infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Impetigo
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Malaria
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Mastitis postpartum
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.6%
6/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.2%
7/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.6%
4/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Ophthalmia neonatorum
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.4%
3/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Otitis media
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Paronychia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
2/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Postpartum sepsis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Primary syphilis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Puerperal infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
9.2%
20/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
5.4%
6/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.8%
2/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Septic rash
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Tinea manuum
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.3%
3/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.7%
1/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Umbilical sepsis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
6.1%
14/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
5.0%
6/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
11.5%
25/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
8.0%
9/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
9.2%
21/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.5%
3/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vaginitis chlamydial
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Viral rash
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vulvitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.9%
9/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.3%
4/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vulvovaginitis chlamydial
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Genital injury
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.3%
3/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
4/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Uterine cervical laceration
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
5.6%
1/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
20.0%
4/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
4.6%
10/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
4.5%
5/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.7%
1/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Blood glucose decreased
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
2/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Blood pressure increased
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.3%
3/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Body temperature increased
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Creatinine renal clearance
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Creatinine renal clearance decreased
|
5.0%
1/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
10.0%
2/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.4%
17/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.4%
9/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
23.1%
3/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Investigations
Treponema test positive
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Metabolism and nutrition disorders
Hypoglycaemia neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
27.6%
60/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
13.4%
15/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
15.4%
2/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.1%
7/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.9%
9/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Nervous system disorders
Neonatal seizure
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Afterbirth pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.5%
8/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
2/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Hypoxic ischaemic encephalopathy neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Meconium in amniotic fluid
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Morning sickness
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.3%
3/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.3%
3/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
2/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged rupture of membranes
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
2/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.3%
3/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.87%
2/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.1%
7/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
3.3%
4/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.83%
1/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.7%
2/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.5%
3/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.7%
1/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal dyspnoea
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.8%
4/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
1.4%
3/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.7%
1/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.92%
2/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.7%
1/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Erythema toxicum neonatorum
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
7.7%
1/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Skin and subcutaneous tissue disorders
Transient neonatal pustular melanosis
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.46%
1/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Surgical and medical procedures
Episiotomy
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.44%
1/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.89%
1/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.6%
6/229 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
2.5%
3/121 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/18 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/20 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/217 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/112 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
0.00%
0/13 • For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
|
Additional Information
IMPAACT Clinicaltrials.gov Coordinator
Family Health International (FHI 360)
Phone: (919) 405-1429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER