Trial Outcomes & Findings for A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 (NCT NCT05406583)
NCT ID: NCT05406583
Last Updated: 2026-05-22
Results Overview
An infant is classified as a "study drug-related" safety failure for the primary safety study objective if any of the following occurred after the initial study drug dosing through two weeks after permanent discontinuation of the study drug (i.e., two weeks after off treatment date): * Grade 3 or 4 Adverse Event (AE) assessed as related to study drug, or * Death (Grade 5 AE) assessed as related to the study drug, or * Life-threatening AE assessed as related to study drug, or * AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
96 participants
Primary outcome timeframe
Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2
Results posted on
2026-05-22
Participant Flow
Participants enrolled between 05OCT2022 and 21JAN2025 at US and non-US clinical research sites. Cohort 1 Strata 1A and 1B opened to accrual simultaneously; Stratum 1C opened to accrual after the interim analysis of Strata 1A and 1B supported the opening of Stratum 1C. Cohort 2 Strata 2A and 2B opened to accrual simultaneously after the protocol team determined the DTG dose, dosing regimen and formulations for Cohort 2 based on the Cohort 1 PK and safety data. There were 48 M-I pairs enrolled.
Participant milestones
| Measure |
Infant Cohort 1 Stratum 1A
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant Cohort 1 Stratum 1B
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant: Cohort 1 Stratum 1C
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant: Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) and through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Infant: Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Maternal: Cohort 1 Stratum 1A
Mothers of infants in Cohort 1 Stratum 1A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 1 Stratum 1B
Mothers of infants in Cohort 1 Stratum 1B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery)
|
Maternal: Cohort 1 Stratum 1C
Mothers of infants in Cohort 1 Stratum 1C with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 2 Stratum 2A
Mothers of infants in Cohort 2 Stratum 2A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 2 Stratum 2B
Mothers of infants in Cohort 2 Stratum 2B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
14
|
16
|
6
|
6
|
6
|
14
|
16
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
12
|
13
|
6
|
6
|
6
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Infant Cohort 1 Stratum 1A
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant Cohort 1 Stratum 1B
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant: Cohort 1 Stratum 1C
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant: Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) and through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Infant: Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Maternal: Cohort 1 Stratum 1A
Mothers of infants in Cohort 1 Stratum 1A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 1 Stratum 1B
Mothers of infants in Cohort 1 Stratum 1B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery)
|
Maternal: Cohort 1 Stratum 1C
Mothers of infants in Cohort 1 Stratum 1C with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 2 Stratum 2A
Mothers of infants in Cohort 2 Stratum 2A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 2 Stratum 2B
Mothers of infants in Cohort 2 Stratum 2B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
Baseline characteristics by cohort
| Measure |
Infant: Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant: Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant: Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Infant: Cohort 2 Stratum 2A
n=14 Participants
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Infant: Cohort 2 Stratum 2B
n=16 Participants
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Maternal: Cohort 1 Stratum 1A
n=6 Participants
Mothers of infants in Cohort 1 Stratum 1A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 1 Stratum 1B
n=6 Participants
Mothers of infants in Cohort 1 Stratum 1B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery)
|
Maternal: Cohort 1 Stratum 1C
n=6 Participants
Mothers of infants in Cohort 1 Stratum 1C with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 2 Stratum 2A
n=14 Participants
Mothers of infants in Cohort 2 Stratum 2A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery)
|
Maternal: Cohort 2 Stratum 2B
n=16 Participants
Mothers of infants in Cohort 2 Stratum 2B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery)
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
6 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
6 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
14 Participants
n=14 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
16 Participants
n=16 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
—
|
—
|
—
|
—
|
—
|
48 Participants
n=48 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
0 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
0 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
0 Participants
n=14 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
0 Participants
n=16 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=48 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
0 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
0 Participants
n=6 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
0 Participants
n=14 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
0 Participants
n=16 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=48 Participants • Infant Age, Categorical. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
|
Age, Continuous
|
2.5 days
n=6 Participants • Infant Age, Continuous. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
3.5 days
n=6 Participants • Infant Age, Continuous. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
2.5 days
n=6 Participants • Infant Age, Continuous. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
3 days
n=14 Participants • Infant Age, Continuous. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
4 days
n=16 Participants • Infant Age, Continuous. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
—
|
—
|
—
|
—
|
—
|
3 days
n=48 Participants • Infant Age, Continuous. Not applicable for mothers. Baseline maternal age is shown in a separate measure.
|
|
Age, Customized
Gestational age at birth
|
38.50 weeks
n=6 Participants • Not applicable for mothers. Mothers do not have a gestational age at birth baseline measurement.
|
38.93 weeks
n=6 Participants • Not applicable for mothers. Mothers do not have a gestational age at birth baseline measurement.
|
38.93 weeks
n=6 Participants • Not applicable for mothers. Mothers do not have a gestational age at birth baseline measurement.
|
39.14 weeks
n=14 Participants • Not applicable for mothers. Mothers do not have a gestational age at birth baseline measurement.
|
39.07 weeks
n=16 Participants • Not applicable for mothers. Mothers do not have a gestational age at birth baseline measurement.
|
—
|
—
|
—
|
—
|
—
|
39.04 weeks
n=48 Participants • Not applicable for mothers. Mothers do not have a gestational age at birth baseline measurement.
|
|
Region of Enrollment
United States
|
1 participants
n=6 Participants
|
2 participants
n=6 Participants
|
3 participants
n=6 Participants
|
10 participants
n=14 Participants
|
1 participants
n=16 Participants
|
3 participants
n=6 Participants
|
1 participants
n=6 Participants
|
2 participants
n=6 Participants
|
10 participants
n=14 Participants
|
1 participants
n=16 Participants
|
17 participants
n=96 Participants
|
|
Age, Customized
Maternal age at entry
|
—
|
—
|
—
|
—
|
—
|
30.4 years
n=6 Participants • Maternal Age, Continuous. Baseline infant age is shown in a separate measure.
|
27.1 years
n=6 Participants • Maternal Age, Continuous. Baseline infant age is shown in a separate measure.
|
24.6 years
n=6 Participants • Maternal Age, Continuous. Baseline infant age is shown in a separate measure.
|
29.4 years
n=14 Participants • Maternal Age, Continuous. Baseline infant age is shown in a separate measure.
|
30.2 years
n=16 Participants • Maternal Age, Continuous. Baseline infant age is shown in a separate measure.
|
29.7 years
n=48 Participants • Maternal Age, Continuous. Baseline infant age is shown in a separate measure.
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=14 Participants
|
10 Participants
n=16 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=14 Participants
|
16 Participants
n=16 Participants
|
78 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
6 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
18 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
10 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=14 Participants
|
15 Participants
n=16 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=14 Participants
|
15 Participants
n=16 Participants
|
86 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
2 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
2 Participants
n=16 Participants
|
32 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=14 Participants
|
13 Participants
n=16 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=14 Participants
|
13 Participants
n=16 Participants
|
52 Participants
n=96 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
7 Participants
n=96 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
4 Participants
n=96 Participants
|
|
Region of Enrollment
South Africa
|
0 participants
n=6 Participants
|
1 participants
n=6 Participants
|
1 participants
n=6 Participants
|
0 participants
n=14 Participants
|
13 participants
n=16 Participants
|
1 participants
n=6 Participants
|
0 participants
n=6 Participants
|
1 participants
n=6 Participants
|
0 participants
n=14 Participants
|
13 participants
n=16 Participants
|
15 participants
n=96 Participants
|
|
Region of Enrollment
Thailand
|
5 participants
n=6 Participants
|
3 participants
n=6 Participants
|
2 participants
n=6 Participants
|
4 participants
n=14 Participants
|
2 participants
n=16 Participants
|
2 participants
n=6 Participants
|
5 participants
n=6 Participants
|
3 participants
n=6 Participants
|
4 participants
n=14 Participants
|
2 participants
n=16 Participants
|
16 participants
n=96 Participants
|
|
Breastfeeding Status/Intent to Breastfeed at Enrollment
Yes
|
0 Participants
n=6 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
2 Participants
n=6 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
0 Participants
n=6 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
3 Participants
n=14 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
11 Participants
n=16 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
—
|
—
|
—
|
—
|
—
|
16 Participants
n=48 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
|
Breastfeeding Status/Intent to Breastfeed at Enrollment
No
|
6 Participants
n=6 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
4 Participants
n=6 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
6 Participants
n=6 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
11 Participants
n=14 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
5 Participants
n=16 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
—
|
—
|
—
|
—
|
—
|
32 Participants
n=48 Participants • Breastfeeding Status/Intent to Breastfeed at Enrollment for the mother/infant pair, recorded for the infant
|
|
Maternal HIV-1 Viral Load at Entry: Below Limit of Quantification
Yes
|
—
|
—
|
—
|
—
|
—
|
4 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
6 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
4 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
7 Participants
n=14 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
14 Participants
n=16 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
35 Participants
n=48 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
|
Maternal HIV-1 Viral Load at Entry: Below Limit of Quantification
No
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
0 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
2 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
6 Participants
n=14 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
1 Participants
n=16 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
10 Participants
n=48 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
|
Maternal HIV-1 Viral Load at Entry: Below Limit of Quantification
Missing
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
0 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
0 Participants
n=6 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
1 Participants
n=14 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
1 Participants
n=16 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
3 Participants
n=48 Participants • Maternal HIV-1 Viral Load at Entry. Infants did not have HIV-1 at Entry.
|
PRIMARY outcome
Timeframe: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2Population: All infants who received at least one dose of DTG.
An infant is classified as a "study drug-related" safety failure for the primary safety study objective if any of the following occurred after the initial study drug dosing through two weeks after permanent discontinuation of the study drug (i.e., two weeks after off treatment date): * Grade 3 or 4 Adverse Event (AE) assessed as related to study drug, or * Death (Grade 5 AE) assessed as related to the study drug, or * Life-threatening AE assessed as related to study drug, or * AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
Outcome measures
| Measure |
Cohort 2 Stratum 2B
n=16 Participants
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=18 Participants
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
n=14 Participants
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
n=30 Participants
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
Proportion of Infants Classified as Study Drug-related Safety Failures Through 2 Weeks After DTG-Discontinuation.
|
0 proportion of participants
Interval 0.0 to 0.17
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.15
|
0 proportion of participants
Interval 0.0 to 0.19
|
0 proportion of participants
Interval 0.0 to 0.1
|
PRIMARY outcome
Timeframe: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2Population: All infants who received at least one dose of DTG.
An infant is classified as a safety failure for the primary safety study objective if any of the following occurred after the initial study drug dosing through two weeks after permanent discontinuation of the study drug (i.e., two weeks after off treatment date): * Grade 3 or 4 AE, or * Death (Grade 5 AE)
Outcome measures
| Measure |
Cohort 2 Stratum 2B
n=16 Participants
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=18 Participants
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
n=14 Participants
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
n=30 Participants
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
Proportion of Infants Classified as Safety Failures Through 2 Weeks After DTG-Discontinuation.
|
0.06 proportion of participants
Interval 0.0 to 0.26
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.15
|
0.21 proportion of participants
Interval 0.06 to 0.47
|
0.13 proportion of participants
Interval 0.05 to 0.28
|
PRIMARY outcome
Timeframe: Initial study drug dosing through study drug discontinuation, up to 3 weeks for Cohort 1 and up to 8 weeks for Cohort 2Population: All infants who received at least one dose of DTG.
An infant is considered not able to tolerate the study drug if the infant experiences problems taking the study drug or experiences any AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
Outcome measures
| Measure |
Cohort 2 Stratum 2B
n=16 Participants
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=18 Participants
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
n=14 Participants
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
n=30 Participants
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
Proportion of Infants Who Are Not Able to Tolerate the Study Drug.
|
0 proportion of participants
Interval 0.0 to 0.17
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.15
|
0 proportion of participants
Interval 0.0 to 0.19
|
0 proportion of participants
Interval 0.0 to 0.1
|
PRIMARY outcome
Timeframe: Entry visit intensive PK sampling (0-5 days of life): pre-dose, and 1-2, 4-8, 11-13, 22-26 and 48-72 hours post-dose; 7 Days (+3 days) Post Initial Dose intensive PK sampling: pre-dose, and 1-2, 22-26 hours post-dosePopulation: All Cohort 1 PK evaluable infants
Cohort 1 Trough concentration (Ctrough) based on intensive PK sampling for DTG. Ctrough is defined as the concentration at the last measurable time point or at the end of dosing interval.
Outcome measures
| Measure |
Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
DTG Ctrough for Cohort 1
7 Days (+3 days) Post Initial Dose
|
—
|
0.265 ug/mL
Geometric Coefficient of Variation 29.6
|
0.636 ug/mL
Geometric Coefficient of Variation 61.2
|
1.98 ug/mL
Geometric Coefficient of Variation 29.0
|
—
|
—
|
—
|
|
DTG Ctrough for Cohort 1
Entry
|
—
|
0.212 ug/mL
Geometric Coefficient of Variation 193
|
0.488 ug/mL
Geometric Coefficient of Variation 99.4
|
1.11 ug/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Entry visit intensive PK sampling (0-5 days of life): pre-dose, and 1-2, 4-8, 11-13, 22-26 and 48-72 hours post-dosePopulation: All Cohort 1 PK evaluable infants
Cohort 1 area under the concentration-time curve at 48-hour interval (AUC0-48) based on intensive PK sampling for DTG at Entry visit.
Outcome measures
| Measure |
Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
DTG AUC0-48 for Cohort 1 at Entry Visit
|
—
|
23.3 h*ug/mL
Geometric Coefficient of Variation 109
|
63.5 h*ug/mL
Geometric Coefficient of Variation 62.7
|
113 h*ug/mL
Geometric Coefficient of Variation 30.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days (+3 days) post initial dose intensive PK sampling: pre-dose, and 1-2, 22-26 hours post-dosePopulation: All Cohort 1 PK evaluable infants
Cohort 1 area under the concentration-time curve at 24-hour interval (AUC0-24) based on intensive PK sampling for DTG at 7 Days (+3 days) Post Initial Dose Visit.
Outcome measures
| Measure |
Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
DTG AUC0-24 for Cohort 1 at 7 Days (+3 Days) Post Initial Dose Visit
|
—
|
8.77 h*ug/mL
Geometric Coefficient of Variation 47.9
|
19.9 h*ug/mL
Geometric Coefficient of Variation 53.8
|
52.9 h*ug/mL
Geometric Coefficient of Variation 36.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days (+3 days) post initial dose PK sampling: pre-dose, and 1-2, 6-10, 22-26 hours post-dose, and prior to the next dose (for infants continuing to receive DTG every 48 hours)Population: All Cohort 2 PK evaluable infants, including the 5 participants (3 in Stratum 2A and 2 in Stratum 2B) with PK sampling performed at the last dose of Q48h dosing (first dose of Q24h dosing).
Cohort 2 Trough concentration (Ctrough) based on intensive PK sampling for DTG. For the five participants with PK sampling performed at the last dose of Q48h dosing (first dose of Q24h dosing, and a 48-hour sample was not collected), Ctrough was estimated using the terminal slope of preceding points. Based on the protocol-defined visit windows, the 7 days post initial dose visit may occur between 7 and 15 days of life. At this visit, participants may be receiving either Q48h or Q24h dosing, depending on the timing of their first dose day and the day for the 7 days post initial dose visit.
Outcome measures
| Measure |
Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=2 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=9 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=12 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=21 Participants
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
DTG Ctrough for Cohort 2 at 7 Days (+3 Days) Post Initial Dose Visit
|
—
|
2.85 ug/mL
Geometric Coefficient of Variation 27.4
|
1.45 ug/mL
Geometric Coefficient of Variation 45.4
|
0.739 ug/mL
Geometric Coefficient of Variation 218
|
0.987 ug/mL
Geometric Coefficient of Variation 147
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 4 intensive PK sampling (22-33 days of life): pre-dose, and 1-2, 6-10, 22-26 hours post-dosePopulation: All Cohort 2 PK evaluable infants
Cohort 2 Trough concentration (Ctrough) based on intensive PK sampling for DTG
Outcome measures
| Measure |
Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=11 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=12 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
DTG Ctrough for Cohort 2 at Week 4
|
—
|
3.13 ug/mL
Geometric Coefficient of Variation 40.4
|
1.86 ug/mL
Geometric Coefficient of Variation 128
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days (+3 days) post initial dose PK sampling: pre-dose, and 1-2, 6-10, 22-26 hours post-dose, and prior to the next dose (for infants continuing to receive DTG every 48 hours)Population: All Cohort 2 PK evaluable infants, including the 5 participants (3 in Stratum 2A and 2 in Stratum 2B) with PK sampling performed at the last dose of Q48h dosing (first dose of Q24h dosing). For these participants, a 48-hour sample was not collected, and AUC0-tau was calculated using the imputed Ctrough.
Cohort 2 area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-tau) based on intensive PK sampling for DTG at 7 Days (+3 days) Post Initial Dose Visit. Based on the protocol-defined visit windows, the 7 days post initial dose visit may occur between 7 and 15 days of life. At this visit, participants may be receiving either Q48h or Q24h dosing, depending on the timing of their first dose day and the day for the 7 days post initial dose visit.
Outcome measures
| Measure |
Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=2 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=9 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=12 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=21 Participants
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
DTG AUC(0-tau) for Cohort 2 at 7 Days (+3 Days) Post Initial Dose Visit
|
—
|
90.0 h*ug/mL
Geometric Coefficient of Variation 29.5
|
159 h*ug/mL
Geometric Coefficient of Variation 33.9
|
110 h*ug/mL
Geometric Coefficient of Variation 80.5
|
129 h*ug/mL
Geometric Coefficient of Variation 65.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 4 intensive PK sampling (22-33 days of life): pre-dose, and 1-2, 6-10, 22-26 hours post-dosePopulation: All Cohort 2 PK evaluable infants
Cohort 2 area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-tau) based on intensive PK sampling for DTG at Week 4 visit
Outcome measures
| Measure |
Cohort 2 Stratum 2B
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=11 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=12 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
DTG AUC(0-tau) for Cohort 2 at Week 4 Visit
|
—
|
119 h*ug/mL
Geometric Coefficient of Variation 24.7
|
81.2 h*ug/mL
Geometric Coefficient of Variation 60
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Initial study drug dosing through Week 16An infant is classified as a "study drug-related" safety failure for the secondary study safety objective if any of the following occurred after the initial study drug dosing through Week 16: * Grade 3 or 4 AE assessed as related to study drug, or * Death (Grade 5 AE) assessed as related to the study drug, or * Life-threatening AE assessed as related to study drug, or * AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
Outcome measures
| Measure |
Cohort 2 Stratum 2B
n=16 Participants
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=18 Participants
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
n=14 Participants
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
n=30 Participants
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
Proportion of Infants Classified as Study Drug-related Safety Failures Through 16 Weeks.
|
0 proportion of participants
Interval 0.0 to 0.17
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.15
|
0 proportion of participants
Interval 0.0 to 0.19
|
0 proportion of participants
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: Initial study drug dosing through Week 16An infant is classified as a safety failure for the secondary study safety objective if any of the following occurred after the initial study drug dosing through Week 16: * Grade 3 or 4 AE, or * Death (Grade 5 AE)
Outcome measures
| Measure |
Cohort 2 Stratum 2B
n=16 Participants
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 1 Stratum 1A
n=6 Participants
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 Participants
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 Participants
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=18 Participants
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
n=14 Participants
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
n=30 Participants
DTG-naive and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
Proportion of Infants Classified as Safety Failures Through 16 Weeks.
|
0.19 proportion of participants
Interval 0.05 to 0.42
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.39
|
0 proportion of participants
Interval 0.0 to 0.15
|
0.29 proportion of participants
Interval 0.1 to 0.54
|
0.23 proportion of participants
Interval 0.12 to 0.39
|
Adverse Events
Cohort 1 Stratum 1A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1 Stratum 1B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1 Stratum 1C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1 Total
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 2 Stratum 2A
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 2 Stratum 2B
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 2 Total
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Stratum 1A
n=6 participants at risk
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 participants at risk
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 participants at risk
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=18 participants at risk
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
n=14 participants at risk
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Stratum 2B
n=16 participants at risk
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
n=30 participants at risk
DTG-naïve and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
Other adverse events
| Measure |
Cohort 1 Stratum 1A
n=6 participants at risk
DTG-naïve infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1B
n=6 participants at risk
DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension administered orally, with 1st dose at Entry visit (2-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Stratum 1C
n=6 participants at risk
DTG-naïve infants receiving 2 doses of DTG 5 mg dispersible tablets administered orally, with 1st dose at Entry visit (0-5 days of life) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 1 Total
n=18 participants at risk
DTG-naive and DTG-exposed infants receiving two doses of DTG 0.5 mg/kg liquid suspension (for Strata 1A and 1B) or 5 mg dispersible tablets (for Stratum 1C) administered orally, with 1st dose at Entry visit (0-5 days of life for Strata 1A and 1C; 2-5 days of life for Stratum 1B) and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
|
Cohort 2 Stratum 2A
n=14 participants at risk
DTG-naïve infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Stratum 2B
n=16 participants at risk
DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
Cohort 2 Total
n=30 participants at risk
DTG-naïve and DTG-exposed infants receiving DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
14.3%
2/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
11.1%
2/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Congenital, familial and genetic disorders
Congenital umbilical hernia
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Gastrointestinal disorders
Infantile diarrhoea
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
12.5%
2/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Gastrointestinal disorders
Infantile vomiting
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
14.3%
2/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
General disorders
Fever neonatal
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
General disorders
Swelling
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
11.1%
2/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Body tinea
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Ophthalmia neonatorum
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
14.3%
2/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Otitis media
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Tinea faciei
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
11.1%
2/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
14.3%
2/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
35.7%
5/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
25.0%
4/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
30.0%
9/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
14.3%
2/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
18.8%
3/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
5/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Blood potassium increased
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
14.3%
2/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Cardiac murmur
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Haemoglobin decreased
|
33.3%
2/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
50.0%
3/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
83.3%
5/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
55.6%
10/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
42.9%
6/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
56.2%
9/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
50.0%
15/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
50.0%
3/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
27.8%
5/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
21.4%
3/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
31.2%
5/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
26.7%
8/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
18.8%
3/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
10.0%
3/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Pregnancy, puerperium and perinatal conditions
Leukopenia neonatal
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
14.3%
2/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
12.5%
2/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
13.3%
4/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
21.4%
3/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
12.5%
2/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
5/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
21.4%
3/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
12.5%
2/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
5/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
12.5%
2/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
10.0%
3/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Rash neonatal
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
12.5%
2/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.7%
2/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
16.7%
1/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
5.6%
1/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
6.2%
1/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/6 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/18 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
7.1%
1/14 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
0.00%
0/16 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
3.3%
1/30 • From study entry up to 16 Weeks
Safety events are reported for all infants who received at least one dose of DTG. All Grade 1-5 serious and other targeted adverse events were reported. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of AE data collection is provided in protocol Section 7.2. In addition, grading of axillary measured fever and plasma creatinine grading in this study follows protocol section 7.3.3. Adverse Events were not collected from mothers.
|
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