Trial Outcomes & Findings for ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection (NCT NCT02075593)
NCT ID: NCT02075593
Last Updated: 2022-10-06
Results Overview
Blood samples were collected at indicated timepoints for Pharmacokinetic (PK) analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
Results posted on
2022-10-06
Participant Flow
This is a single arm open-label study in women who became pregnant while participating in study ING117172 (NCT01910402).
In this study, 4 pregnant women were enrolled. Participant flow data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
Participant milestones
| Measure |
DTG/ABC/3TC - Mother
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
Infants Born to Pregnant Women Who Received at Least One Dose of Study Treatment
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
DTG/ABC/3TC - Mother
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection
Baseline characteristics by cohort
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
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|---|---|
|
Age, Continuous
|
29.3 Years
STANDARD_DEVIATION 5.56 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European heritage
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population consists of all participants in the Safety Population (comprised of all participants \[pregnant women\] who received at least one dose of study treatment) who had at least 1 non-missing PK assessment.
Blood samples were collected at indicated timepoints for Pharmacokinetic (PK) analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Area Under the Plasma Concentration Time Curve at Steady State During a Dosing Interval (AUC [0-tau]) for Dolutegravir
Trimester 2 (Weeks 18-26 of pregnancy)
|
55.045 Micrograms*hours per milliliter
Interval 37.918 to 79.907
|
|
Area Under the Plasma Concentration Time Curve at Steady State During a Dosing Interval (AUC [0-tau]) for Dolutegravir
Trimester 3 (Weeks 30-36 of pregnancy)
|
42.473 Micrograms*hours per milliliter
Interval 27.613 to 65.33
|
|
Area Under the Plasma Concentration Time Curve at Steady State During a Dosing Interval (AUC [0-tau]) for Dolutegravir
8-12 Weeks postpartum
|
78.917 Micrograms*hours per milliliter
Interval 53.195 to 117.075
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
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|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Dolutegravir
Trimester 2 (Weeks 18-26 of pregnancy)
|
4.420 Micrograms per milliliter
Interval 2.906 to 6.724
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|
Maximum Observed Plasma Concentration (Cmax) for Dolutegravir
Trimester 3 (Weeks 30-36 of pregnancy)
|
3.424 Micrograms per milliliter
Interval 2.038 to 5.753
|
|
Maximum Observed Plasma Concentration (Cmax) for Dolutegravir
8-12 Weeks Postpartum
|
5.578 Micrograms per milliliter
Interval 3.866 to 8.049
|
PRIMARY outcome
Timeframe: 24 hours post dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Drug Concentration at the End of Dosing Interval (Ctau) for Dolutegravir
Trimester 2 (Weeks 18-26 of pregnancy)
|
930.1 Nanograms per milliliter
Interval 562.0 to 1539.3
|
|
Drug Concentration at the End of Dosing Interval (Ctau) for Dolutegravir
Trimester 3 (Weeks 30-36 of pregnancy)
|
657.5 Nanograms per milliliter
Interval 266.1 to 1624.4
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|
Drug Concentration at the End of Dosing Interval (Ctau) for Dolutegravir
8-12 Weeks Postpartum
|
2154.7 Nanograms per milliliter
Interval 901.4 to 5150.5
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
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|---|---|
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Apparent Oral Clearance (CL/F) for Dolutegravir
Trimester 2 (Weeks 18-26 of pregnancy)
|
0.739 Liters per hour
Interval 0.484 to 1.13
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|
Apparent Oral Clearance (CL/F) for Dolutegravir
Trimester 3 (Weeks 30-36 of pregnancy)
|
0.952 Liters per hour
Interval 0.559 to 1.62
|
|
Apparent Oral Clearance (CL/F) for Dolutegravir
8-12 Weeks Postpartum
|
0.464 Liters per hour
Interval 0.062 to 3.476
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Steady State Volume of Distribution (Vss/F) After Extravascular Administration for Dolutegravir
Trimester 2 (Weeks 18-26 of pregnancy)
|
9.665 Liters
Interval 6.651 to 14.044
|
|
Steady State Volume of Distribution (Vss/F) After Extravascular Administration for Dolutegravir
Trimester 3 (Weeks 30-36 of pregnancy)
|
12.326 Liters
Interval 7.878 to 19.285
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|
Steady State Volume of Distribution (Vss/F) After Extravascular Administration for Dolutegravir
8-12 Weeks Postpartum
|
6.326 Liters
Interval 0.048 to 833.336
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
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|---|---|
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Half-life (T1/2) for Dolutegravir
Trimester 2 (Weeks 18-26 of pregnancy)
|
9.215 Hours
Standard Deviation 1.8968
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|
Half-life (T1/2) for Dolutegravir
Trimester 3 (Weeks 30-36 of pregnancy)
|
9.401 Hours
Standard Deviation 3.0322
|
|
Half-life (T1/2) for Dolutegravir
8-12 Weeks Postpartum
|
9.699 Hours
Standard Deviation 3.0427
|
PRIMARY outcome
Timeframe: Up to Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment.
Blood samples were collected for analysis of hemoglobin. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Number of participants (Pregnant Women) with maximum severity of post-Baseline emergent toxicities with respect to hemoglobin has been presented.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
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|---|---|
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Number of Participants (Pregnant Women) With Maximum Severity of Post-Baseline Emergent Hematology Toxicities: Hemoglobin
Grade 1
|
1 Participants
|
|
Number of Participants (Pregnant Women) With Maximum Severity of Post-Baseline Emergent Hematology Toxicities: Hemoglobin
Grade 2
|
0 Participants
|
|
Number of Participants (Pregnant Women) With Maximum Severity of Post-Baseline Emergent Hematology Toxicities: Hemoglobin
Grade 3
|
0 Participants
|
|
Number of Participants (Pregnant Women) With Maximum Severity of Post-Baseline Emergent Hematology Toxicities: Hemoglobin
Grade 4
|
0 Participants
|
PRIMARY outcome
Timeframe: At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of chemistry parameters including ALT and AST.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
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|---|---|
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Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Baseline (Day 1), n=4
|
10.8 International units per Liter
Standard Deviation 5.56
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Week 4, n=4
|
15.3 International units per Liter
Standard Deviation 4.43
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Week 8, n=4
|
19.3 International units per Liter
Standard Deviation 17.21
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Week 12, n=4
|
11.0 International units per Liter
Standard Deviation 3.16
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Week 16, n=4
|
10.8 International units per Liter
Standard Deviation 2.36
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Week 20, n=4
|
10.3 International units per Liter
Standard Deviation 7.27
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Week 24, n=1
|
19.0 International units per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Week 32, n=2
|
28.0 International units per Liter
Standard Deviation 15.56
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Baseline (Day 1), n=4
|
14.8 International units per Liter
Standard Deviation 4.19
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Week 4, n=4
|
17.3 International units per Liter
Standard Deviation 2.22
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Week 8, n=4
|
17.3 International units per Liter
Standard Deviation 6.18
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Week 12, n=4
|
15.0 International units per Liter
Standard Deviation 1.83
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Week 16, n=4
|
14.8 International units per Liter
Standard Deviation 2.63
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Week 20, n=4
|
16.3 International units per Liter
Standard Deviation 3.30
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Week 24, n=1
|
20.0 International units per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Week 32, n=2
|
24.0 International units per Liter
Standard Deviation 8.49
|
PRIMARY outcome
Timeframe: Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of chemistry parameters including ALT and AST. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Change From Baseline in Chemistry Parameters: ALT and AST
ALT, Week 4, n=4
|
4.5 International units per Liter
Standard Deviation 6.03
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
ALT, Week 8, n=4
|
8.5 International units per Liter
Standard Deviation 11.79
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
ALT, Week 12, n=4
|
0.3 International units per Liter
Standard Deviation 3.30
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
ALT, Week 16, n=4
|
0.0 International units per Liter
Standard Deviation 3.56
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
ALT, Week 20, n=4
|
-0.5 International units per Liter
Standard Deviation 1.73
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
ALT, Week 24, n=1
|
0.0 International units per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
ALT, Week 32, n=2
|
19.5 International units per Liter
Standard Deviation 14.85
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
AST, Week 4, n=4
|
2.5 International units per Liter
Standard Deviation 4.43
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
AST, Week 8, n=4
|
2.5 International units per Liter
Standard Deviation 2.38
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
AST, Week 12, n=4
|
0.3 International units per Liter
Standard Deviation 3.10
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
AST, Week 16, n=4
|
0.0 International units per Liter
Standard Deviation 3.37
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
AST, Week 20, n=4
|
1.5 International units per Liter
Standard Deviation 1.29
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
AST, Week 24, n=1
|
-1.0 International units per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: ALT and AST
AST, Week 32, n=2
|
11.0 International units per Liter
Standard Deviation 8.49
|
PRIMARY outcome
Timeframe: At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 4, n=4
|
5.0 Micromoles per Liter
Standard Deviation 1.83
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 8, n=4
|
5.5 Micromoles per Liter
Standard Deviation 2.65
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 12, n=4
|
4.5 Micromoles per Liter
Standard Deviation 1.29
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Baseline (Day 1), n=4
|
7.3 Micromoles per Liter
Standard Deviation 3.77
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 16, n=4
|
4.5 Micromoles per Liter
Standard Deviation 1.29
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 20, n=4
|
4.5 Micromoles per Liter
Standard Deviation 1.29
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 24, n=1
|
7.0 Micromoles per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 32, n=2
|
6.5 Micromoles per Liter
Standard Deviation 0.71
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Baseline (Day 1), n=4
|
57.73 Micromoles per Liter
Standard Deviation 16.661
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 4, n=4
|
50.50 Micromoles per Liter
Standard Deviation 2.990
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 8, n=4
|
51.58 Micromoles per Liter
Standard Deviation 3.067
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 12, n=4
|
50.68 Micromoles per Liter
Standard Deviation 3.293
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 16, n=4
|
47.45 Micromoles per Liter
Standard Deviation 2.001
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 20, n=4
|
50.60 Micromoles per Liter
Standard Deviation 6.424
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 24, n=1
|
63.60 Micromoles per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 32, n=2
|
68.90 Micromoles per Liter
Standard Deviation 3.677
|
PRIMARY outcome
Timeframe: Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 4, n=4
|
-2.3 Micromoles per Liter
Standard Deviation 2.06
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 8, n=4
|
-1.8 Micromoles per Liter
Standard Deviation 1.26
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 12, n=4
|
-2.8 Micromoles per Liter
Standard Deviation 2.99
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 16, n=4
|
-2.8 Micromoles per Liter
Standard Deviation 2.99
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 20, n=4
|
-2.8 Micromoles per Liter
Standard Deviation 2.99
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 24, n=1
|
-5.0 Micromoles per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Bilirubin, Week 32, n=2
|
2.0 Micromoles per Liter
Standard Deviation 2.83
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 4, n=4
|
-7.23 Micromoles per Liter
Standard Deviation 14.014
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 8, n=4
|
-6.15 Micromoles per Liter
Standard Deviation 16.700
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 12, n=4
|
-7.05 Micromoles per Liter
Standard Deviation 14.328
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 16, n=4
|
-10.28 Micromoles per Liter
Standard Deviation 17.453
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 20, n=4
|
-7.13 Micromoles per Liter
Standard Deviation 11.154
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 24, n=1
|
-19.10 Micromoles per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine
Creatinine, Week 32, n=2
|
19.10 Micromoles per Liter
Standard Deviation 3.253
|
PRIMARY outcome
Timeframe: At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including hemoglobin.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Absolute Values of the Hematology Parameters: Hemoglobin
Baseline (Day 1), n=4
|
127.8 Grams per Liter
Standard Deviation 11.24
|
|
Absolute Values of the Hematology Parameters: Hemoglobin
Week 4, n=4
|
120.8 Grams per Liter
Standard Deviation 7.23
|
|
Absolute Values of the Hematology Parameters: Hemoglobin
Week 8, n=4
|
113.5 Grams per Liter
Standard Deviation 7.05
|
|
Absolute Values of the Hematology Parameters: Hemoglobin
Week 12, n=4
|
116.5 Grams per Liter
Standard Deviation 7.14
|
|
Absolute Values of the Hematology Parameters: Hemoglobin
Week 16, n=4
|
115.0 Grams per Liter
Standard Deviation 4.69
|
|
Absolute Values of the Hematology Parameters: Hemoglobin
Week 20, n=4
|
115.8 Grams per Liter
Standard Deviation 8.30
|
|
Absolute Values of the Hematology Parameters: Hemoglobin
Week 24, n=1
|
127.0 Grams per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of the Hematology Parameters: Hemoglobin
Week 32, n=2
|
140.5 Grams per Liter
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including hemoglobin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Change From Baseline in Hematology Parameters: Hemoglobin
Week 4, n=4
|
-7.0 Grams per Liter
Standard Deviation 10.17
|
|
Change From Baseline in Hematology Parameters: Hemoglobin
Week 8, n=4
|
-14.3 Grams per Liter
Standard Deviation 7.37
|
|
Change From Baseline in Hematology Parameters: Hemoglobin
Week 12, n=4
|
-11.3 Grams per Liter
Standard Deviation 4.92
|
|
Change From Baseline in Hematology Parameters: Hemoglobin
Week 16, n=4
|
-12.8 Grams per Liter
Standard Deviation 6.65
|
|
Change From Baseline in Hematology Parameters: Hemoglobin
Week 20, n=4
|
-12.0 Grams per Liter
Standard Deviation 4.97
|
|
Change From Baseline in Hematology Parameters: Hemoglobin
Week 24, n=1
|
-14.0 Grams per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Hematology Parameters: Hemoglobin
Week 32, n=2
|
14.0 Grams per Liter
Standard Deviation 8.49
|
PRIMARY outcome
Timeframe: At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 32, n=2
|
5.85 Giga cells per Liter
Standard Deviation 0.636
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Leukocytes, Baseline (Day 1), n=4
|
6.48 Giga cells per Liter
Standard Deviation 1.415
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 4, n=4
|
7.88 Giga cells per Liter
Standard Deviation 2.095
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 8, n=4
|
8.43 Giga cells per Liter
Standard Deviation 1.959
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 12, n=4
|
9.15 Giga cells per Liter
Standard Deviation 2.053
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 16, n=4
|
9.23 Giga cells per Liter
Standard Deviation 1.821
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 20, n=4
|
10.03 Giga cells per Liter
Standard Deviation 2.848
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 24, n=1
|
12.60 Giga cells per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Platelets, Baseline (Day 1), n=4
|
204.8 Giga cells per Liter
Standard Deviation 37.03
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Platelets, Week 4, n=4
|
200.5 Giga cells per Liter
Standard Deviation 2.38
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Platelets, Week 8, n=4
|
220.8 Giga cells per Liter
Standard Deviation 16.07
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Platelets, Week 12, n=4
|
195.5 Giga cells per Liter
Standard Deviation 25.38
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Platelets, Week 16, n=4
|
198.0 Giga cells per Liter
Standard Deviation 10.80
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Platelets, Week 20, n=4
|
216.5 Giga cells per Liter
Standard Deviation 10.91
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Platelets, Week 24, n=1
|
250.0 Giga cells per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of the Hematology Parameters: Leukocytes and Platelets
Platelets, Week 32, n=2
|
206.0 Giga cells per Liter
Standard Deviation 24.04
|
PRIMARY outcome
Timeframe: Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of studyPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 4, n=4
|
1.40 Giga cells per Liter
Standard Deviation 1.817
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 8, n=4
|
1.95 Giga cells per Liter
Standard Deviation 2.047
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 12, n=4
|
2.68 Giga cells per Liter
Standard Deviation 1.173
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 16, n=4
|
2.75 Giga cells per Liter
Standard Deviation 1.654
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 20, n=4
|
3.55 Giga cells per Liter
Standard Deviation 2.340
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 24, n=1
|
4.90 Giga cells per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Leukocytes, Week 32, n=2
|
-0.65 Giga cells per Liter
Standard Deviation 1.061
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Platelets, Week 4, n=4
|
-4.3 Giga cells per Liter
Standard Deviation 39.09
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Platelets, Week 8, n=4
|
16.0 Giga cells per Liter
Standard Deviation 33.44
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Platelets, Week 12, n=4
|
-9.3 Giga cells per Liter
Standard Deviation 39.08
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Platelets, Week 16, n=4
|
-6.8 Giga cells per Liter
Standard Deviation 47.16
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Platelets, Week 20, n=4
|
11.8 Giga cells per Liter
Standard Deviation 45.49
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Platelets, Week 24, n=1
|
10.0 Giga cells per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Platelets, Week 32, n=2
|
-4.0 Giga cells per Liter
Standard Deviation 50.91
|
PRIMARY outcome
Timeframe: Up to Week 292Population: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment. Number of participants (pregnant women) who discontinued the treatment due to adverse events have been presented.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Number of Participants (Pregnant Women) Who Discontinued the Treatment Due to Adverse Events (AE)
|
0 Participants
|
PRIMARY outcome
Timeframe: At delivery (up to Week 40 of pregnancy)Population: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment.
Data for participants (pregnant women) demonstrated congenital malformations was reported.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Number of Participants (Pregnant Women) Demonstrated Congenital Malformations
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 292 WeeksPopulation: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment
Number of participants (pregnant women) with adverse events (AE) as per severity grades were presented. Grade 1 is mild, grade 2 is moderate, grade 3 is severe or medically significant but not immediately life-threatening and grade 4 is life-threatening consequences; urgent intervention required.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Number of Participants (Pregnant Women) With Adverse Events (AE) as Per Severity Grades
Grade 1
|
2 Participants
|
|
Number of Participants (Pregnant Women) With Adverse Events (AE) as Per Severity Grades
Grade 2
|
2 Participants
|
|
Number of Participants (Pregnant Women) With Adverse Events (AE) as Per Severity Grades
Grade 3
|
0 Participants
|
|
Number of Participants (Pregnant Women) With Adverse Events (AE) as Per Severity Grades
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Time to Cmax (Tmax) for Dolutegravir
Trimester 2 (Weeks 18-26 of pregnancy)
|
3.508 Hours
Standard Deviation 1.7082
|
|
Time to Cmax (Tmax) for Dolutegravir
Trimester 3 (Weeks 30-36 of pregnancy)
|
2.729 Hours
Standard Deviation 0.4877
|
|
Time to Cmax (Tmax) for Dolutegravir
8-12 Weeks Postpartum
|
4.242 Hours
Standard Deviation 2.0522
|
SECONDARY outcome
Timeframe: Pre-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Pre-dose Plasma Concentration (C0) for Dolutegravir
Trimester 2 (Weeks 18-26 of pregnancy)
|
666.9 Nanograms per milliliter
Interval 149.5 to 2974.6
|
|
Pre-dose Plasma Concentration (C0) for Dolutegravir
Trimester 3 (Weeks 30-36 of pregnancy)
|
1084.6 Nanograms per milliliter
Interval 676.7 to 1738.3
|
|
Pre-dose Plasma Concentration (C0) for Dolutegravir
8-12 Weeks Postpartum
|
1225.0 Nanograms per milliliter
Interval 522.8 to 2870.1
|
SECONDARY outcome
Timeframe: At 3 hours and 24 hours post dose in Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartumPopulation: Pharmacokinetic Population
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir
At 3 hours post dose in Trimester 2
|
7.856 Micrograms per milliliter
Interval 4.37 to 14.122
|
|
Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir
At 3 hours post dose in Trimester 3
|
7.371 Micrograms per milliliter
Interval 4.594 to 11.827
|
|
Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir
At 3 hours post dose 8-12 Weeks postpartum
|
6.898 Micrograms per milliliter
Interval 4.36 to 10.914
|
|
Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir
At 24 hours post dose in Trimester 2
|
1.798 Micrograms per milliliter
Interval 0.887 to 3.644
|
|
Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir
At 24 hours post dose in Trimester 3
|
2.065 Micrograms per milliliter
Interval 1.229 to 3.471
|
|
Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir
At 24 hours post dose 8-12 Weeks postpartum
|
2.881 Micrograms per milliliter
Interval 1.503 to 5.52
|
SECONDARY outcome
Timeframe: At delivery (up to Week 40 of pregnancy)Population: Pharmacokinetic Population
Blood samples were collected at the time of delivery for PK analysis of dolutegravir.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Total DTG Concentrations in Plasma From Cord Blood and Maternal Blood at the Time of Delivery
Cord plasma concentration
|
1436.0 Nanograms per milliliter
Standard Deviation 1287.43
|
|
Total DTG Concentrations in Plasma From Cord Blood and Maternal Blood at the Time of Delivery
Maternal plasma concentration
|
1806.3 Nanograms per milliliter
Standard Deviation 1125.04
|
SECONDARY outcome
Timeframe: Up to Week 32 of studyPopulation: Intent-to-Treat Exposed (ITT-E) Population includes all participants (pregnant women) who received at least one dose of study treatment.
Number of participants (pregnant women) with treatment-emergent genotypic and/or phenotypic resistance who met confirmed virologic withdrawal criteria are presented. Genotypic and phenotypic analyses were carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO) and reverse transcriptase (RT), or with their GeneSeq Integrase and PhenoSense Integrase assays.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Number of Participants (Pregnant Women) With Treatment-emergent Genotypic and/or Phenotypic Resistance Who Met Confirmed Virologic Withdrawal Criteria
Participants with genotypic resistance
|
0 Participants
|
|
Number of Participants (Pregnant Women) With Treatment-emergent Genotypic and/or Phenotypic Resistance Who Met Confirmed Virologic Withdrawal Criteria
Participants with phenotypic resistance
|
0 Participants
|
SECONDARY outcome
Timeframe: At delivery (up to Week 40 of pregnancy)Population: Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment.
Participants (pregnant women) with following live birth outcome categories are reported- Vaginal Birth, Planned Caesarean Section, Unscheduled Caesarean Section and Preterm Delivery.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Number of Participants (Pregnant Women) With Live Birth Outcome Categories
Vaginal Birth
|
1 Participants
|
|
Number of Participants (Pregnant Women) With Live Birth Outcome Categories
Planned Caesarean Section
|
2 Participants
|
|
Number of Participants (Pregnant Women) With Live Birth Outcome Categories
Unscheduled Caesarean Section
|
1 Participants
|
|
Number of Participants (Pregnant Women) With Live Birth Outcome Categories
Preterm Delivery
|
1 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
Gestational age is defined as the number of weeks between the first day of the mother's last normal menstrual period and the day of birth. Data for gestational age of infants has been presented.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Gestational Age of Infants
|
38.3 Weeks
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: At birthPopulation: Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
Data for neonatal length and head circumference at birth are reported.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Neonatal Length and Head Circumference at Birth
Neonatal Length
|
51.5 Centimeter
Standard Deviation 3.11
|
|
Neonatal Length and Head Circumference at Birth
Neonatal Head Circumference
|
34.9 Centimeter
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: At birthPopulation: Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
Data for neonatal weight at birth has been reported.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Neonatal Weight at Birth
|
3262.5 Grams
Standard Deviation 731.36
|
SECONDARY outcome
Timeframe: At birthPopulation: Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
Weight of infants at birth were categorized as: Small for Gestational Age (SGA) defined neonates under the 10th percentile in weight, Appropriate for Gestational Age (AGA) characterized neonates between the 10th and 90th percentiles in weight and Large for Gestational Age (LGA) referred to neonates over the 90th percentile in weight.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Number of Infants by Their Weight Categories at Birth
LGA
|
0 Participants
|
|
Number of Infants by Their Weight Categories at Birth
AGA
|
4 Participants
|
|
Number of Infants by Their Weight Categories at Birth
SGA
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 and 5 minutes after birthPopulation: Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
APGAR is a quick test to assess the health of new born. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two with 2 being the best score, then summing up the values obtained from all five categories. APGAR score ranges from 0 to 10 (Higher score indicates better health) where a score of 7 and above is normal. Number of infants by APGAR score at 1 and 5 minutes after birth are presented.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Number of Infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 and 5 Minutes After Birth
1 Minute, Score 0 to 6
|
0 Participants
|
|
Number of Infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 and 5 Minutes After Birth
1 Minute, Score 7 to 10
|
4 Participants
|
|
Number of Infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 and 5 Minutes After Birth
5 Minute, Score 0 to 6
|
0 Participants
|
|
Number of Infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 and 5 Minutes After Birth
5 Minute, Score 7 to 10
|
4 Participants
|
SECONDARY outcome
Timeframe: At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of studyPopulation: Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Percentage of participants (pregnant women) with plasma HIV-1 RNA \<50 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit
Week 4, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit
Week 8, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit
Week 12, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit
Week 16, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit
Week 20, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit
Week 24, n=2
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit
Week 28, n=1
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit
Week 32, n=2
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of studyPopulation: Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles)
Percentage of participants (pregnant women) with plasma HIV-1 RNA \<400 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit
Week 4, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit
Week 8, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit
Week 12, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit
Week 16, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit
Week 20, n=4
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit
Week 24, n=2
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit
Week 28, n=1
|
100 Percentage of participants
|
|
Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit
Week 32, n=2
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of studyPopulation: Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of CD4+ T cell counts using cytometry.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Baseline (Day 1), n=4
|
476.3 Cells per cubic millimeter
Standard Deviation 123.31
|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Week 4, n=4
|
569.5 Cells per cubic millimeter
Standard Deviation 238.51
|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Week 8, n=4
|
569.8 Cells per cubic millimeter
Standard Deviation 296.43
|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Week 12, n=4
|
575.0 Cells per cubic millimeter
Standard Deviation 331.22
|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Week 16, n=4
|
626.8 Cells per cubic millimeter
Standard Deviation 270.63
|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Week 20, n=4
|
791.5 Cells per cubic millimeter
Standard Deviation 524.96
|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Week 24, n=2
|
874.5 Cells per cubic millimeter
Standard Deviation 516.90
|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Week 28, n=1
|
488.0 Cells per cubic millimeter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit
Week 32, n=2
|
677.5 Cells per cubic millimeter
Standard Deviation 40.31
|
SECONDARY outcome
Timeframe: Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of studyPopulation: Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Change From Baseline in CD4+ T Cell Counts by Visit
Week 4, n=4
|
93.3 Cells per cubic millimeter
Standard Deviation 124.64
|
|
Change From Baseline in CD4+ T Cell Counts by Visit
Week 8, n=4
|
93.5 Cells per cubic millimeter
Standard Deviation 174.54
|
|
Change From Baseline in CD4+ T Cell Counts by Visit
Week 12, n=4
|
98.8 Cells per cubic millimeter
Standard Deviation 208.50
|
|
Change From Baseline in CD4+ T Cell Counts by Visit
Week 16, n=4
|
150.5 Cells per cubic millimeter
Standard Deviation 148.73
|
|
Change From Baseline in CD4+ T Cell Counts by Visit
Week 20, n=4
|
315.3 Cells per cubic millimeter
Standard Deviation 402.00
|
|
Change From Baseline in CD4+ T Cell Counts by Visit
Week 24, n=2
|
353.0 Cells per cubic millimeter
Standard Deviation 332.34
|
|
Change From Baseline in CD4+ T Cell Counts by Visit
Week 28, n=1
|
98.0 Cells per cubic millimeter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in CD4+ T Cell Counts by Visit
Week 32, n=2
|
246.0 Cells per cubic millimeter
Standard Deviation 97.58
|
SECONDARY outcome
Timeframe: Up to Week 32 of studyPopulation: Intent-to-Treat Exposed Population
Disease progression included HIV-associated conditions, acquired immunodeficiency syndrome (AIDS) and death. Number of participants (pregnant women) with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.
Outcome measures
| Measure |
DTG/ABC/3TC - Mother
n=4 Participants
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
|---|---|
|
Number of Participants (Pregnant Women) With Disease Progression
|
0 Participants
|
Adverse Events
DTG/ABC/3TC - Mother
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
DTG/ABC/3TC - Infant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTG/ABC/3TC - Mother
n=4 participants at risk
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
DTG/ABC/3TC - Infant
This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
Other adverse events
| Measure |
DTG/ABC/3TC - Mother
n=4 participants at risk
Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
|
DTG/ABC/3TC - Infant
This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.
|
|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
50.0%
2/4 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Infections and infestations
Cystitis
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Infections and infestations
Gastroenteritis
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Infections and infestations
Oral herpes
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Infections and infestations
Respiratory tract infection viral
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Infections and infestations
Vaginal infection
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
General disorders
Asthenia
|
50.0%
2/4 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Nervous system disorders
Migraine
|
25.0%
1/4 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Renal and urinary disorders
Nephropathy
|
50.0%
2/4 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
—
0/0 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER